WoundsNCT05588583
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
A study testing Mepilex Up in people with Wounds and Wound of Skin, run by Molnlycke Health Care AB at 4 sites in United States.
Trial summary
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds, Wound of Skin, Wound Leg
- What is being tested?
- Mepilex Up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Oct 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed consent to participate (including consent for digital imaging)
- Adult aged ≥18 years
- Diagnosed with a chronic, exuding VLU or DFU
- Exudate amount moderate to large
- Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
- For VLU: ABPI (within 3 months) > 0.7. If ABPI > 1.4, then big toe pressure > 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
- For VLU: Willing to be compliant with compression therapy
Who cannot join
- Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
- Circumferential wound
- Known allergy/hypersensitivity to the materials of the dressing
- Patients participating in the DIPLO NBF study
- Use of wound fillers
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Center for Clinical Research, Inc.
Castro Valley, California, 94546
Gayana Sarkisova, CCRC, 800-363-1069 ext. 104, gayana@ccr-trials.com
Alexander Reyzelman, DPM
- Recruiting
Felix Sigal, DPM
Los Angeles, California, 90010
Maira Jackson, MA, maira@lafootpain.com
Felix Sigal, DPM
- Recruiting
University of Miami
Miami, Florida, 33125
Aliette Espinosa, 305-689-3376, a.espinosa2@med.miami.edu
Hadar Lev-Tov, MD
- Recruiting
Serena Group Research Institute
Pittsburgh, Pennsylvania, 15222
Laura Serena, 412-335-0764, lserena@serenagroups.com
Thomas Serena, MD
About this study
Official title: A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.
Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
Read the detailed description
This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. Two indications will be included: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcers (DFU). A total of n=68 participants, approximately 34 per indication, will be recruited at up to 8 centers in the US.
There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.
- Conditions
- Wounds, Wound of Skin, Wound Leg, Wound; Foot, Diabetic Foot Ulcer, Venous Leg Ulcer
- Being tested
- Mepilex Up
- Keywords
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Medical subject headings
- Wounds and Injuries, Foot Injuries, Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex UpDevice
Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal.
Mepilex Up consists of:
- a soft silicone wound contact layer (Safetac)
- a flexible absorbent pad of compressed polyurethane foam
- an outer polyurethane film which is breathable but waterproof
Dressing material content:
Silicone, polyurethane
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care with Mepilex Up | Experimental | All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing. Receives: Device: Mepilex Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound progress of the total effect of treatment using Mepilex Up
Wound progress is the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition by the treating investigator/designee. Wound progress will be assessed as deteriorated, no change, improved, or healed at each visit. Wound area will be measured by an independent evaluator assisted by digital software at each visit and recorded as cm2 using the formula, A= π*L*W/4.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Secondary outcomes (28)
Percentage wound area reduction over time
The percentage of wound area (cm2) reduction over time will be assessed by a formula as the area of an ellipse and measured by an independent evaluator assisted by digital software on all digital photographs taken at each scheduled visit.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Percentage wound volume reduction over time (DFUs only)
The percentage wound volume (cm3) reduction over time will be calculated by a formula from the manually assessed wound depth and the digitally assessed wound area.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Linear wound healing over time
The linear wound healing will be calculated with Gilman's formula (cm/day), G = - (A1-A0)/ {[(P1+P0)/2]*(t1-t0)}, where:
A0 = previous visit area A1 = current visit area P0 = previous visit perimeter P1 = current visit perimeter t0 = previous visit time t1 = current visit time.
Area (A) and Perimeter (P) will be assessed by an independent evaluator assisted by digital software. Perimeter (P) will be measured in cm and Area (A) will be assessed in cm2.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in granulation tissue over time
The area of wound covered by granulation tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in sloughy tissue over time
The area of wound covered by sloughy tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in exudate amount over time
Exudate amount will be captured as a subjective measure from the investigator/designee and assessed as none, scant, small, moderate, or large.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in exudate nature over time
Exudate nature will be captured as a subjective measure from the investigator/designee via the following category descriptive scale: serous, serosanguinous, sanguineous, seropurulent, fibrinous, purulent, hemopurulent, or hemorrhagic.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in peri-wound skin condition over time
The change in peri-wound skin condition over time will be assessed by visual assessment (No/Yes) by investigator/designee for maceration, dry skin, erythema/redness, and other peri-wound skin conditions. The Transepidermal Water Loss, or TEWL, will be an additional variable assessed at every visit for VLU Subjects at a limited number of clinical sites. TEWL measurements will be done using a portable VapoMeter.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in maceration over time
Area of wound covered by macerated tissue (%) will be assessed before debridement in cm2 by an independent evaluator assisted by digital software.
The maximal distance (cm) from as close to the wound edge as possible to the end of maceration, assessed from wound photo, taken before debridement, by an independent evaluator assisted by digital software. The area of maceration will be assessed from a wound photo taken before debridement by an independent evaluator assisted by digital software.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound/Peri-Wound itch score prior to dressing removal over time (PRO)
The Subject itch severity before dressing removal over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates their level of itchiness on a level from 0 to 10, where 0 indicates no itch and 10 is the worst itch.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound pain score during dressing wear over time (PRO)
Subject pain severity during dressing wear over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound pain score related to removal of dressing over time (PRO)
Subject pain severity at dressing removal will be assessed at all follow-up visits using the NRS scale where the Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain. Any pre-procedural or intra-procedural pain medication administered at the time of dressing removal will be recorded.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Trauma to the wound/peri-wound during dressing removal over time
Trauma to the wound will be captured via visual judgement by the investigator/desginee using an ordinal scale of none, very slight, moderate, or high. Trauma to the peri-wound skin will be captured via visual judgement by the investigator/designee using the ordinal scale of none, very slight, moderate, or high.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Primary dressing's ability to be comfortable to wear (PRO)
Subjects will be asked to rate Mepilex Up degree of comfort using a 4-item scale of very poor, poor, good, or very good.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO)
VLU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with compression using a 4-item scale of very poor, poor, good, or very good.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO)
DFU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with offloading using a 4-item scale of very poor, poor, good, or very good.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Evaluation of Wound Quality of Life (QoL) (PRO)
A Wound-QoL-17 questionnaire will be completed by each Subject to measure the disease-specific, health-related QoL of those with chronic wounds. All items assess impairments within the preceding seven days.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Technical Performance (Investigator/designee's evaluation)
Several questions will be asked to evaluate the technical performance properties of Mepilex Up. The following will be assessed by the investigator/designee using no/yes values: 1) Occurrence of strike-through, defined as the inability of the dressing to stay sealed over the wound causing leakage of wound exudate; and 2) Occurrence of product residue in the wound bed or on peri-wound skin after dressing removal. All other properties will be assessed by the investigator/designee using a 4-item scale of very poor, poor, good, very good. These include:
- Ability to absorb exudates with different viscosities,
- Ability to retain exudate,
- Ease of application,
- Ability to conform to the wound during wear,
- Ability to be repositioned during application,
- Inability to adhere to moist wound bed,
- Ability to adhere to healthy, intact skin,
- Ability to stay on during application and use,
- Overall satisfaction with the dressing's properties.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Status of dressing during a routine dressing change or complication
The status of Mepilex Up during a routine dressing change or complication will be assessed by the investigator/designee as strike-through, saturated, displaced/slipping, or other. This will be recorded in the Dressing Log.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Pre-compression edema
The specification of any pre-compression edema prior to applying/changing compression therapy will be assessed by the investigator/designee as:
- 0 (no clinical edema)
- 1+ (≤2 mm indentation)
- 2+ (2-4 mm indentation)
- 3+ (4-6 mm indentation)
- 4+ (6-8 mm indentation)
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Compression removed/changed/applied
Assessment of compression by the investigator/designee will cover:
- Compression removal (No/Yes)
- Compression changed/applied (No/Yes)
- Type of compression used
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Compliance with compression
The investigator/designee will evaluate Subject compliance with compression. Assessment will include being fully compliant (defined as 7 out of 7 days with compression), moderately compliant (defined as 1 to 3 days without compression out of 7 days), or not compliant (defined as >3 days without compression out of 7 days).
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Offloading Use/Type
The assessment of offloading will cover if it were used (No/Yes) and specification of offloading type by the investigator/designee.
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Compliance to offloading
The investigator/designee will evaluate Subject compliance with offloading. Assessment will include being fully compliant (defined as 7 out of 7 days with offloading), moderately compliant (defined as 1 to 3 days without offloading out of 7 days), or not compliant (defined as >3 days without offloading out of 7 days).
Measured: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Wear time (days)
Wear time will be determined from the Subject Dressing Log at each visit by collecting:
- Date of dressing application/change
- Reason for change application/change
- Lot/batch
- Size
- Quantity
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Debridement performed
The following debridement details will be recorded for each Subject at each visit:
- Debridement performed (No/Yes)
- Debridement method
- Ease of debridement (Very easy/Easy/Difficult/Very Difficult)
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Cleansing performed
The following cleansing details will be recorded for each Subject at each visit:
- Cleansing performed (No/Yes)
- Type of cleansing agent used
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Evaluation of all reported adverse events and device deficiencies
If any reported adverse events or device deficiencies are reported, an evaluation will take place to determine root cause.
Measured: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start31 Oct 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The model is a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to local standard of care.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hadar Lev-Tov, MD, MAS, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588583
- Sponsor's protocol ID
- DIPLO01
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney J, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. Wound Repair Regen. 2015 Jan-Feb;23(1):1-13. doi: 10.1111/wrr.12245. Epub 2015 Feb 13.
PubMed 25486905Tickle J. Wound exudate: a survey of current understanding and clinical competency. Br J Nurs. 2016 Jan 28-Feb 10;25(2):102-9. doi: 10.12968/bjon.2016.25.2.102.
PubMed 27119542Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25.
PubMed 27112627Jones JE, Robinson J, Barr W, Carlisle C. Impact of exudate and odour from chronic venous leg ulceration. Nurs Stand. 2008 Jul 16-22;22(45):53-4, 56, 58 passim. doi: 10.7748/ns2008.07.22.45.53.c6592.
PubMed 18686695Maume S, Van De Looverbosch D, Heyman H, Romanelli M, Ciangherotti A, Charpin S. A study to compare a new self-adherent soft silicone dressing with a self-adherent polymer dressing in stage II pressure ulcers. Ostomy Wound Manage. 2003 Sep;49(9):44-51.
PubMed 14581709Moore Z, Strapp H. Managing the problem of excess exudate. Br J Nurs. 2015 Aug 13-Sep 19;24(15):S12, S14-7. doi: 10.12968/bjon.2015.24.Sup15.S12.
PubMed 26266558Rippon M, Davies P, White R. Taking the trauma out of wound care: the importance of undisturbed healing. J Wound Care. 2012 Aug;21(8):359-60, 362, 364-8. doi: 10.12968/jowc.2012.21.8.359.
PubMed 22885308Gorin DR, Cordts PR, LaMorte WW, Manzoian JO. The influence of wound geometry on the measurement of wound healing rates in clinical trials. J Vasc Surg. 1996 Mar;23(3):524-8. doi: 10.1016/s0741-5214(96)80021-8.
PubMed 8601898Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
PubMed 21621130Augustin M, Conde Montero E, Zander N, Baade K, Herberger K, Debus ES, Diener H, Neubert T, Blome C. Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds. Wound Repair Regen. 2017 Sep;25(5):852-857. doi: 10.1111/wrr.12583. Epub 2017 Nov 2.
PubMed 29080332Rippon M WM, Bielfeldt S. An evaluation of properties related to wear time of four dressings during a five-day period. Wounds UK. 2015;11(1):45-54.
Young T, Clark M, Augustin M, Carville K, Curran J, Flour M, et al. International consensus. Optimising wellbeing in people living with a wound. An expert working group review. Wounds International; London 2012.
Chadwick P, McCardle J. Exudate management using a gelling fibre dressing. The Diabetic Foot Journal. 2015;18(1):43-8.
World Union of Wound Healing Societies (WUWHS). Principles of best practice: Wound exudate and the role of dressings. A consensus document. 2019.
European Wound Management Association (EWMA). Position document: Wound bed preparation in practice. London: MEP Ltd. 2004.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up
- ClinicalTrials.gov ID
- NCT05588583
- Acronym / sponsor ID
- DIPLO01
- Conditions
- Wounds, Wound of Skin, Wound Leg, Wound; Foot, Diabetic Foot Ulcer, Venous Leg Ulcer
- Keywords
- Diabetic Foot Ulcer, Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.
Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
Detailed description
This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. Two indications will be included: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcers (DFU). A total of n=68 participants, approximately 34 per indication, will be recruited at up to 8 centers in the US.
There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The model is a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to local standard of care.
| Arm | Type | Receives |
|---|---|---|
| Supportive Care with Mepilex Up | Experimental | Device: Mepilex UpAll Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed consent to participate (including consent for digital imaging)
- Adult aged ≥18 years
- Diagnosed with a chronic, exuding VLU or DFU
- Exudate amount moderate to large
- Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
Key exclusion criteria (5 listed)
- Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
- Circumferential wound
- Known allergy/hypersensitivity to the materials of the dressing
- Patients participating in the DIPLO NBF study
- Use of wound fillers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepilex UpMepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal. Mepilex Up consists of: * a soft silicone wound contact layer (Safetac) * a flexible absorbent pad of compressed polyurethane foam * an outer polyurethane film which is breathable but waterproof Dressing material content: Silicone, polyurethane | Device | Supportive Care with Mepilex Up |
Primary outcome
Wound progress of the total effect of treatment using Mepilex Up
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound progress is the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition by the treating investigator/designee. Wound progress will be assessed as deteriorated, no change, improved, or healed at each visit. Wound area will be measured by an independent evaluator assisted by digital software at each visit and recorded as cm2 using the formula, A= π*L*W/4.
28 secondary outcomes
Percentage wound area reduction over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Percentage wound volume reduction over time (DFUs only)
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Linear wound healing over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in granulation tissue over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in sloughy tissue over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in exudate amount over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in exudate nature over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in peri-wound skin condition over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Change in maceration over time
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound/Peri-Wound itch score prior to dressing removal over time (PRO)
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound pain score during dressing wear over time (PRO)
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound pain score related to removal of dressing over time (PRO)
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Trauma to the wound/peri-wound during dressing removal over time
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Primary dressing's ability to be comfortable to wear (PRO)
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO)
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO)
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Evaluation of Wound Quality of Life (QoL) (PRO)
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Technical Performance (Investigator/designee's evaluation)
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Status of dressing during a routine dressing change or complication
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Pre-compression edema
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Compression removed/changed/applied
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Compliance with compression
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Offloading Use/Type
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Compliance to offloading
Time frame: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Wear time (days)
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Debridement performed
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Cleansing performed
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Evaluation of all reported adverse events and device deficiencies
Time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 25486905Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney J, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. Wound Repair Regen. 2015 Jan-Feb;23(1):1-13. doi: 10.1111/wrr.12245. Epub 2015 Feb 13.
- Background: PubMed 27119542Tickle J. Wound exudate: a survey of current understanding and clinical competency. Br J Nurs. 2016 Jan 28-Feb 10;25(2):102-9. doi: 10.12968/bjon.2016.25.2.102.
- Background: PubMed 27112627Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25.
- Background: PubMed 18686695Jones JE, Robinson J, Barr W, Carlisle C. Impact of exudate and odour from chronic venous leg ulceration. Nurs Stand. 2008 Jul 16-22;22(45):53-4, 56, 58 passim. doi: 10.7748/ns2008.07.22.45.53.c6592.
- Background: PubMed 14581709Maume S, Van De Looverbosch D, Heyman H, Romanelli M, Ciangherotti A, Charpin S. A study to compare a new self-adherent soft silicone dressing with a self-adherent polymer dressing in stage II pressure ulcers. Ostomy Wound Manage. 2003 Sep;49(9):44-51.
- Background: PubMed 26266558Moore Z, Strapp H. Managing the problem of excess exudate. Br J Nurs. 2015 Aug 13-Sep 19;24(15):S12, S14-7. doi: 10.12968/bjon.2015.24.Sup15.S12.
- Background: PubMed 22885308Rippon M, Davies P, White R. Taking the trauma out of wound care: the importance of undisturbed healing. J Wound Care. 2012 Aug;21(8):359-60, 362, 364-8. doi: 10.12968/jowc.2012.21.8.359.
- Background: PubMed 8601898Gorin DR, Cordts PR, LaMorte WW, Manzoian JO. The influence of wound geometry on the measurement of wound healing rates in clinical trials. J Vasc Surg. 1996 Mar;23(3):524-8. doi: 10.1016/s0741-5214(96)80021-8.
- Background: PubMed 21621130Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
- Background: PubMed 29080332Augustin M, Conde Montero E, Zander N, Baade K, Herberger K, Debus ES, Diener H, Neubert T, Blome C. Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds. Wound Repair Regen. 2017 Sep;25(5):852-857. doi: 10.1111/wrr.12583. Epub 2017 Nov 2.
- BackgroundRippon M WM, Bielfeldt S. An evaluation of properties related to wear time of four dressings during a five-day period. Wounds UK. 2015;11(1):45-54.
- BackgroundYoung T, Clark M, Augustin M, Carville K, Curran J, Flour M, et al. International consensus. Optimising wellbeing in people living with a wound. An expert working group review. Wounds International; London 2012.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hadar Lev-Tov, MD, MAS principal investigator
University of Miami
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Up in people with Wounds and Wound of Skin, run by Molnlycke Health Care AB at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet Kandrevas, MD, MS (734-358-2174, janet.kandrevas@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound progress of the total effect of treatment using Mepilex Up (time frame: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05588583, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.