Venous Leg UlcerNCT03589586
Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers
A study testing DermACELL AWM in people with Venous Leg Ulcer, run by LifeNet Health at 7 sites in United States.
Trial summary
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- DermACELL AWM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Jun 2018to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit if the subject has a diagnosis of Type 1 or Type 2 diabetes as defined by the American Diabetes Association
- Have a full-thickness venous leg ulcer that does not penetrate into the muscle, tendon or bone.
- Have a single target ulcer
- Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
- Have a venous stasis ulcer that has been present for at least 30 days.
- Have a Clinical severity, Etiology or cause, Anatomy and Pathophysiology ulcer classification (CEAP) Grade C6: an open venous ulcer
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- Have an absence of infection based on Infectious Disease Society of America criteria
- Have adequate circulation to the affected lower extremity, defined as an Ankle-brachial index (ABI) greater than 0.75.
- Have the ability to comply with off-loading (if required for specific wound), compression and dressing change requirements
- Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments
- Have provided written authorization for use and disclosure of protected health information
- Have a life expectancy of greater than 6 months
Who cannot join
- Be pregnant or lactating
- Have a venous leg ulcer on the dorsum of the foot or more than 50% of the ulcer is below the malleolus
- Have circulating hemoglobin A1c exceeding 12% within 90 days of the screening visit
- Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
- Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
- Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
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- Have the wound treated with biomedical or topical growth factors within the previous 30 days before the screening visit
- Need for any additional concomitant dressing material other than the ones approved for this study
- Have clinical signs of an infection at the study ulcer site
- Have the inability to tolerate compression bandage
- Have a known or suspected disease of the immune system
- Have an active or untreated malignancy or active, uncontrolled connective tissue disease
- Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit
- Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
- Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit
- Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening
- Have active Charcot disease
- Have undergone treatment with a living skin equivalent within the last 4 weeks before the screening visit
- Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
- Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
South Florida Podiatry
Deerfield Beach, Florida, 33442
Limb Preservation Platform
Fresno, California, 93710
LA Foot and Ankle Clinic
Los Angeles, California, 90057
Purvis Moyer Foot and Ankle Center
Rocky Mount, North Carolina, 27804
Doctors Research Network
South Miami, Florida, 33143
Arizona Regional Medical Research
Tucson, Arizona, 85710
Southern Arizona VA Health Care System Department of Podiatry
Tucson, Arizona, 85723
About this study
Official title: An Open-Label Trial to Assess the Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU).
Read the detailed description
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU). After eligibility is determined at a screening visit, VLU subjects will be entered into a 2 week run-in period of conventional wound care with moist wound therapy and multilayer compression bandage.
At baseline, those continuing to meet eligibility criteria will be randomized to either DermACELL or conventional care wound management at a ratio of 1:1. The appropriate size of DermACELL will be applied to the wound of subjects in the DermACELL arm. The ADM will be attached with sutures, sterile adhesive strips, or bioadhesive, and covered with a dressing. For subjects in the conventional care wound management arm, the debrided wound will undergo a moist-wound therapy consisting of alginates, foams, or hydrogels, and will be covered with a gauze that is appropriate for the type of wound (moist or dry).
Subsequent study visits will occur every week until 100% re-epithelialization or up to 16 weeks after treatment (whichever comes first).
- Conditions
- Venous Leg Ulcer
- Being tested
- DermACELL AWM
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermACELL AWMOther
Also called Acellular dermal matrix
DermACELL AWM is a sterile, ready to use acellular dermal matrix
| Study group | Role | What they receive |
|---|---|---|
| DermACELL AWM + Conventional Care | Experimental | DermACELL AWM, acellular dermal matrix, plus conventional wound care- DermACELL AWM will be applied at the Baseline visit. Conventional wound care will include advanced wound dressings and multilayer compression. Receives: Other: DermACELL AWM |
| Conventional Care | No intervention | Conventional wound care will include advanced wound dressings and multilayer compression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
effect of DermACELL on the proportion of chronic venous leg ulcers that have achieved 100% re-epithelialization without drainage or dressing requirements
Measured: 16 Weeks
Secondary outcomes (1)
Time to wound closure
Change in wound area over time
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start25 Jun 2018
- Primary completion15 Jan 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies 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
- Model description
- Multicenter, randomized, controlled, open-label trial comparing DermACELL AWM to conventional care
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589586
- Sponsor's protocol ID
- CR-18-004
- Status last verified
- Mar 2021
- First submitted
- 5 Jul 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial to Assess the Clinical Effectiveness of DermACELL AWM in Subjects With Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03589586
- Acronym / sponsor ID
- CR-18-004
- Conditions
- Venous Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 18 Jul 2018 (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.
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU).
Detailed description
This study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of DermACELL in subjects with a single target chronic venous leg ulcer (VLU). After eligibility is determined at a screening visit, VLU subjects will be entered into a 2 week run-in period of conventional wound care with moist wound therapy and multilayer compression bandage.
At baseline, those continuing to meet eligibility criteria will be randomized to either DermACELL or conventional care wound management at a ratio of 1:1. The appropriate size of DermACELL will be applied to the wound of subjects in the DermACELL arm. The ADM will be attached with sutures, sterile adhesive strips, or bioadhesive, and covered with a dressing. For subjects in the conventional care wound management arm, the debrided wound will undergo a moist-wound therapy consisting of alginates, foams, or hydrogels, and will be covered with a gauze that is appropriate for the type of wound (moist or dry).
Subsequent study visits will occur every week until 100% re-epithelialization or up to 16 weeks after treatment (whichever comes first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, controlled, open-label trial comparing DermACELL AWM to conventional care
| Arm | Type | Receives |
|---|---|---|
| DermACELL AWM + Conventional Care | Experimental | Other: DermACELL AWMDermACELL AWM, acellular dermal matrix, plus conventional wound care- DermACELL AWM will be applied at the Baseline visit. Conventional wound care will include advanced wound dressings and multilayer compression. |
| Conventional Care | No intervention | –Conventional wound care will include advanced wound dressings and multilayer compression. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit if the subject has a diagnosis of Type 1 or Type 2 diabetes as defined by the American Diabetes Association
- Have a full-thickness venous leg ulcer that does not penetrate into the muscle, tendon or bone.
- Have a single target ulcer
- Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
- Have a venous stasis ulcer that has been present for at least 30 days.
Key exclusion criteria (20 listed)
- Be pregnant or lactating
- Have a venous leg ulcer on the dorsum of the foot or more than 50% of the ulcer is below the malleolus
- Have circulating hemoglobin A1c exceeding 12% within 90 days of the screening visit
- Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
- Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
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 |
|---|---|---|
| DermACELL AWMAlso: Acellular dermal matrixDermACELL AWM is a sterile, ready to use acellular dermal matrix | Other | DermACELL AWM + Conventional Care |
Primary outcome
Healing Rate
Time frame: 16 Weeks
effect of DermACELL on the proportion of chronic venous leg ulcers that have achieved 100% re-epithelialization without drainage or dressing requirements
1 secondary outcome
Time to wound closure
Time frame: 16 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermACELL AWM in people with Venous Leg Ulcer, run by LifeNet Health at 7 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Healing Rate (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021.