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The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers.
DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DermACELL | Experimental | DermACELL acellular dermal matrix will be used to treat subjects diagnosed with an ulcer of the lower extremity (diabetic foot ulcer or venous stasis ulcer). |
|
| Conventional care dressings | Placebo Comparator | Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diagnosis of either diabetic foot ulcer or venous stasis ulcer. |
|
| GraftJacket | Active Comparator | GraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermACELL | Other | Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers). |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed. | The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits 2 weeks apart. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks | The proportion of subjects with closed wounds at 12 weeks and weekly thereafter will be compared in subjects treated with DermACELL, GraftJacket (Diabetic foot ulcer subjects only) and conventional care wound management. A comparison of the proportion of subjects who received a second application of acellular dermal matrix will be made between the DermACELL and GraftJacket arms in those subjects with diabetic foot ulcers. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (AE), changes in vital signs, ankle-brachial index (ABI) and physical examination findings. | Safety of the interventions will be measured by the incidence of treatment-emergent AEs, changes in vital signs, ABI and physical examination. | 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Moore, Ph.D. | LifeNet Health, Scientific Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Advanced Wound Care | Montgomery | Alabama | 36111 | United States | ||
| Southern Arizona VA Health Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26933467 | Result | Walters J, Cazzell S, Pham H, Vayser D, Reyzelman A. Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Eplasty. 2016 Feb 4;16:e10. eCollection 2016. | |
| 28544150 | Result |
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|
| GraftJacket | Other | Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers). |
|
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| Conventional Care Dressings | Other | Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:
A secondary dressing may be desired to add either loft or cushion. |
|
| 24 weeks |
| Tucson |
| Arizona |
| 85723 |
| United States |
| ILD Research Center | Carlsbad | California | 92009 | United States |
| Center for Clinical Research | Castro Valley | California | 94546 | United States |
| Limb Preservation Platform | Fresno | California | 93720 | United States |
| Limb Preservation Platform | Fresno | California | 93721 | United States |
| Fairfield County Foot Surgeons | Norwalk | Connecticut | 06851 | United States |
| Andrews Research and Education Institute | Gulf Breeze | Florida | 32561 | United States |
| Rosalind Franklin University, CLEAR | North Chicago | Illinois | 60064 | United States |
| Boston Medical College | Boston | Massachusetts | 02118 | United States |
| Wound Institute and Reseach Center | Dunmore | Pennsylvania | 18512 | United States |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| Cazzell S, Vayser D, Pham H, Walters J, Reyzelman A, Samsell B, Dorsch K, Moore M. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017 May;25(3):483-497. doi: 10.1111/wrr.12551. Epub 2017 Jun 12. |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |
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