DiabetesNCT03626623
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
A study testing Cytal Wound Matrix 1-Layer in people with Diabetes and Diabetic Foot, run by Integra LifeSciences Corporation at 3 sites in United States.
Trial summary
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2
- What is being tested?
- Cytal Wound Matrix 1-Layer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 May 2019to 18 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form by subject or legally authorized representative.
- Stated willingness to comply with all study procedures and availability for the duration of the study. Subject is able and willing to tolerate non-removable offloading device for the duration of the run-in and intervention phases of the study.
- Subject is male or female and at least 21years of age.
- Subject has a clinical diagnosis of type 1 or type 2 diabetes.
- Subject's current foot ulcer(s) has been present for > 30 days and ≤ 365 days.
Show all 15Show fewer
- Subject's current foot ulcer(s), post-debridement is/are predominantly below the malleoli and on the plantar surface of the foot.
- Subject's foot ulcer(s) must be Wagner type 1 or type 2.
- Post debridement, subject's ulcer(s) are free of necrotic debris and appear to be comprised of healthy, vascularized tissue.
- All qualifying ulcers are ≥ 5cm away from any other ulcer on the same foot.
- Subject's ulcer(s) is ≥ 1cm2 and ≤ 20cm2 at randomization (length x width).
- Subject's HbA1C reading is ≤10%.
- Subject's Serum Creatinine ≤ 3.0mg/dL.
- Subject has adequate circulation to the foot as measured by Ankle-Brachial Index (ABI) ≥ 0.7.
- Negative pregnancy test at randomization for women.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subject is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
- Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
- Subject report of concurrent participation in another clinical trial that involves a drug.
- The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
- Subject has clinical evidence of gangrene on any part of the affected foot.
Show all 24Show fewer
- The subject's ulcer(s) is/are due to a non-diabetic etiology, ulcers of arterial, venous stasis, pressure, radiation, traumatic, rheumatoid, vasculitis, collagen vascular disease, or other non-diabetic etiologies.
- Subject has unstable Charcot foot, Charcot foot with a bony prominence(s) or Charcot amputation.
- Qualifying wound(s) is connected to another ulcer via a fistula.
- Subject has one or more medical condition(s) including: renal, hepatic, hematological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this wound healing study.
- Subject has or has had a malignant disease (other than basal cell carcinoma) that has not been in remission for at least five years.
- Subject is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such during the course of the study.
- Subject has acute osteomyelitis of the affected foot.
- Subject's ulcer(s) is accompanied by active cellulitis.
- Subject has received growth factor or enzymatic therapy within 2 weeks of consent.
- Subject is currently receiving or has received radiation, radiologic implants, or chemotherapy.
- Subject is allergic to any of the primary or secondary dressing materials, including occlusive dressings and the adhesives on such dressings.
- Subject's ulcer(s) has decreased in size by >30% during the run-in phase.
- Subject's ulcer(s) has increased in size by >50% during the run-in phase.
- Subject's ulcer(s) has tunnels or sinus tracts that cannot be completely debrided.
- Subject has severe malnutrition as evidenced by albumin <2.0 g/dL.
- Subject has a bleeding disorder as documented by a diagnosis of a bleeding disorder.
- Subject is on dialysis.
- Any DFU(s) is infected and has not been treated for any clinically suspected infection prior to application of any product.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Limb Preservation Platform, Inc.
Fresno, California, 93710
MedStar Health Research Institute
Hyattsville, Maryland, 20782
Louisiana State University Health Science Center (LSUHSC)
New Orleans, Louisiana, 70112
About this study
Official title: A Prospective, Randomized, Controlled Trial Comparing Cytal Wound Matrix 1-Layer to Standard of Care (SOC) in the Management of Diabetic Foot Ulcers (DFUs)
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.
Read the detailed description
This is a prospective, two-armed, multi-center randomized controlled trial (RCT) comparing Cytal Wound Matrix 1-Layer intervention to standard of care (SOC) intervention in patients presenting with diabetic foot ulcers (DFU). Up to one hundred and fifty patients recruited from US based medical centers and randomized (using a 2(active):1(control) randomization scheme) to receive either Cytal Wound Matrix 1-Layer intervention or standard of care intervention.Complete wound closure incidence, wound healing rates, wound recurrence, and various health related quality of life (HRQOL) outcomes will be compared between study arms. Additionally, a cost effective analysis (i.e. direct and indirect costs) and review of individual and group changes in narcotic prescription patterns will also be evaluated. While incidence of wound closure rates will be evaluated through 12 weeks, protocol defined patient follow-up is for two years.
Data will be captured for remaining study objectives during these two years. An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee (CEC) will adjudicate all adverse events (AEs) and serious adverse events (SAEs).
- Being tested
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Keywords
- Diabetes, Foot Ulcer
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytal Wound Matrix 1-LayerDevice
Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.
Standard of Care (SOC)Other
Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Placebo comparator | The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. Receives: Other: Standard of Care (SOC) |
| Cytal Wound Matrix 1-Layer | Active comparator | The application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU). Receives: Device: Cytal Wound Matrix 1-Layer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Wounds With Wound Closure
The primary endpoint of the study is to measure the incidence of complete wound closure (defined as 100% epithelialization) between randomized groups. Number of wounds was calculated as the total across all participants.
Measured: up to 12 weeks
Secondary outcomes (14)
Wound Size Change
Measure changes in wound size, measured in cm2/week between randomized groups.
Measured: up to 12 weeks
Complete Wound Closure Time
Measure time to complete wound closure between randomized groups.
Measured: up to 12 weeks
Wound Recurrence
Measure wound recurrence after healing is complete between randomized groups.
Measured: at 26 week visit and 52 week visit
Short Form-20 (SF-20)
The Short Form-20 is a 20-item questionnaire used to assess generic health outcomes from the participant's perspective. Scores are linearly measured from 0 (worst) to 100 (best) health functioning scores, respectively.
Measured: Baseline visit, visit #7, visit #13, 26 wk. visit, and 52 wk.visit
Diabetic Foot Ulcer Scale- Short Form (DFS-SF)
The diabetic foot ulcer scale- short form (DFS-SF) is a 29-item questionnaire designed to assess the impact of diabetic foot ulcers (DFUs) and their intervention on quality of life of participants diagnosed with diabetes. Scores measured from 0 (lower) to 100 (higher) quality of life, respectively.
Measured: Baseline visit, 26 week visit, and 52 week visit
Visual Analogue Scale (VAS) for Pain
The visual analogue scale (VAS) is a psychometric response scale for pain. It measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a vertical line on a 10 cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in cm with a higher score (100) indicating greater pain intensity.
Measured: Up to 52 week visit (until study completion)
Katz Index of Independence in Activities of Daily Living (KATZ ADL)
The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e. dependence) or one (i.e. independence). This will be completed with the aid of a trained study staff member.
Measured: Baseline visit, visit 7, visit 13, 26 wk visit, and 52 wk visit
Adverse Events Frequency
This outcome measures diabetic foot ulcer (DFU) related adverse event frequency including unexpected adverse device events (UADEs) or serious adverse experiences (SAEs) throughout the duration of the study as well as evaluate such adverse event frequencies between randomized groups.
Measured: up to 52 week visit (until study completion)
Narcotic Prescription Changes Between Trial Arms
This outcome measures changes in number of diabetic foot ulcer (DFU) related narcotic prescriptions by study participant and between randomized groups.
Measured: up to 52 week visit (until study completion)
Participant Ambulatory Status
This outcome measures any changes in ambulatory status (i.e. bed, wheel chair, walk w/ assistance, or walk independent) by study participant and between randomized groups.
Measured: up to 52 week visit (until study completion)
Return to Work Status
This outcome measures differences in "return to work status" and/or "reported work status", activities of daily living, or disability status by study participant and between randomized groups.
Measured: up to 52 week visit (until study completion)
Diabetic Foot Ulcer (DFU) Specific Ancillary Medical Care
This outcome measures the incidence of diabetic foot ulcer (DFU) specific related medical care a study participant receives outside of the medical care provided by the investigator. Examples of ancillary care include, but are not limited to, emergency room (ER) visits, urgent care visits, outside medical procedures such as surgery, etc. The incidence of subjects requiring ancillary medical care will be tabulated and compared between randomized groups. This data will be collected via two questions (i.e. "Did participant receive any ancillary medical care?" and "If "yes", then specify where"). Responses are verified using source documentation.
Measured: up to 52 week visit (until study completion)
Diabetic Foot Ulcer (DFU) Related Direct Product(s) Costs
This outcome measures direct costs of the products by total cost per subject stratified by healed vs. non healed DFU.
Measured: up to 52 week visit (until study completion)
Indirect Diabetic Foot Ulcer (DFU) Product(s) Costs
This outcome measures total indirect and incidental costs of diabetic foot ulcer products used per study participant by each visit.
Measured: up to 52 week visit (until study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start21 May 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Why it stopped: Sponsor Discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allison Matthews, Study chair, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626623
- Sponsor's protocol ID
- CR2017-006
- Status last verified
- Aug 2021
- First submitted
- 12 Jun 2018
- Last updated
- 25 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chen YH, DeMets DL, Lan KK. Increasing the sample size when the unblinded interim result is promising. Stat Med. 2004 Apr 15;23(7):1023-38. doi: 10.1002/sim.1688.
PubMed 15057876Dumville JC, O'Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013 Jul 12;2013(7):CD009101. doi: 10.1002/14651858.CD009101.pub3.
PubMed 23846869Wu L, Norman G, Dumville JC, O'Meara S, Bell-Syer SE. Dressings for treating foot ulcers in people with diabetes: an overview of systematic reviews. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD010471. doi: 10.1002/14651858.CD010471.pub2.
PubMed 26171906Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.
PubMed 14986739Yazdanpanah L, Nasiri M, Adarvishi S. Literature review on the management of diabetic foot ulcer. World J Diabetes. 2015 Feb 15;6(1):37-53. doi: 10.4239/wjd.v6.i1.37.
PubMed 25685277Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1.
PubMed 24186882Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999 May;22(5):692-5. doi: 10.2337/diacare.22.5.692.
PubMed 10332667
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial Comparing Cytal Wound Matrix 1-Layer to Standard of Care (SOC) in the Management of Diabetic Foot Ulcers (DFUs)
- ClinicalTrials.gov ID
- NCT03626623
- Acronym / sponsor ID
- CR2017-006
- Keywords
- Diabetes, Foot Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Discretion
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Posted 15 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard care intervention.
Detailed description
This is a prospective, two-armed, multi-center randomized controlled trial (RCT) comparing Cytal Wound Matrix 1-Layer intervention to standard of care (SOC) intervention in patients presenting with diabetic foot ulcers (DFU). Up to one hundred and fifty patients recruited from US based medical centers and randomized (using a 2(active):1(control) randomization scheme) to receive either Cytal Wound Matrix 1-Layer intervention or standard of care intervention.Complete wound closure incidence, wound healing rates, wound recurrence, and various health related quality of life (HRQOL) outcomes will be compared between study arms. Additionally, a cost effective analysis (i.e. direct and indirect costs) and review of individual and group changes in narcotic prescription patterns will also be evaluated. While incidence of wound closure rates will be evaluated through 12 weeks, protocol defined patient follow-up is for two years.
Data will be captured for remaining study objectives during these two years. An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee (CEC) will adjudicate all adverse events (AEs) and serious adverse events (SAEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Placebo comparator | Other: Standard of Care (SOC)The usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. |
| Cytal Wound Matrix 1-Layer | Active comparator | Device: Cytal Wound Matrix 1-LayerThe application of the Cytal Wound Matrix 1-Layer device according to the Cytal Wound Matrix 1-Layer instructions for use (IFU). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form by subject or legally authorized representative.
- Stated willingness to comply with all study procedures and availability for the duration of the study. Subject is able and willing to tolerate non-removable offloading device for the duration of the run-in and intervention phases of the study.
- Subject is male or female and at least 21years of age.
- Subject has a clinical diagnosis of type 1 or type 2 diabetes.
Key exclusion criteria (24 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Subject is pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
- Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
- Subject report of concurrent participation in another clinical trial that involves a drug.
- The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
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 |
|---|---|---|
| Cytal Wound Matrix 1-LayerCytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use. | Device | Cytal Wound Matrix 1-Layer |
| Standard of Care (SOC)Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings. | Other | Standard of Care (SOC) |
Primary outcome
Number of Wounds With Wound Closure
Time frame: up to 12 weeks
The primary endpoint of the study is to measure the incidence of complete wound closure (defined as 100% epithelialization) between randomized groups. Number of wounds was calculated as the total across all participants.
14 secondary outcomes
Wound Size Change
Time frame: up to 12 weeks
Complete Wound Closure Time
Time frame: up to 12 weeks
Wound Recurrence
Time frame: at 26 week visit and 52 week visit
Short Form-20 (SF-20)
Time frame: Baseline visit, visit #7, visit #13, 26 wk. visit, and 52 wk.visit
Diabetic Foot Ulcer Scale- Short Form (DFS-SF)
Time frame: Baseline visit, 26 week visit, and 52 week visit
Visual Analogue Scale (VAS) for Pain
Time frame: Up to 52 week visit (until study completion)
Katz Index of Independence in Activities of Daily Living (KATZ ADL)
Time frame: Baseline visit, visit 7, visit 13, 26 wk visit, and 52 wk visit
Adverse Events Frequency
Time frame: up to 52 week visit (until study completion)
Narcotic Prescription Changes Between Trial Arms
Time frame: up to 52 week visit (until study completion)
Participant Ambulatory Status
Time frame: up to 52 week visit (until study completion)
Return to Work Status
Time frame: up to 52 week visit (until study completion)
Diabetic Foot Ulcer (DFU) Specific Ancillary Medical Care
Time frame: up to 52 week visit (until study completion)
Diabetic Foot Ulcer (DFU) Related Direct Product(s) Costs
Time frame: up to 52 week visit (until study completion)
Indirect Diabetic Foot Ulcer (DFU) Product(s) Costs
Time frame: up to 52 week visit (until study completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15057876Chen YH, DeMets DL, Lan KK. Increasing the sample size when the unblinded interim result is promising. Stat Med. 2004 Apr 15;23(7):1023-38. doi: 10.1002/sim.1688.
- Background: PubMed 23846869Dumville JC, O'Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013 Jul 12;2013(7):CD009101. doi: 10.1002/14651858.CD009101.pub3.
- Background: PubMed 26171906Wu L, Norman G, Dumville JC, O'Meara S, Bell-Syer SE. Dressings for treating foot ulcers in people with diabetes: an overview of systematic reviews. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD010471. doi: 10.1002/14651858.CD010471.pub2.
- Background: PubMed 14986739Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.
- Background: PubMed 25685277Yazdanpanah L, Nasiri M, Adarvishi S. Literature review on the management of diabetic foot ulcer. World J Diabetes. 2015 Feb 15;6(1):37-53. doi: 10.4239/wjd.v6.i1.37.
- Background: PubMed 24186882Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1.
- Background: PubMed 10332667Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999 May;22(5):692-5. doi: 10.2337/diacare.22.5.692.
- Description of Cytal Wound Matrix Products (including Cytal Wound Matrix 1-Layer)Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
Allison Matthews study chair
Integra LifeSciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytal Wound Matrix 1-Layer in people with Diabetes and Diabetic Foot, run by Integra LifeSciences Corporation at 3 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 15 inclusion and 24 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: stopped early, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Wounds With Wound Closure (time frame: up to 12 weeks). 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 NCT03626623, which also lists 7 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 25 Aug 2021.