Diabetic Foot Ulcer
Conditions
Keywords
Diabetic foot ulcer, Venous stasis ulcer, Wound of the lower extremity, Skin substitute, Acellular Dermal Matrix
Brief summary
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
Detailed description
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.
Interventions
OTHERDermACELL
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).
OTHERGraftJacket
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).
OTHERConventional Care Dressings
Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing: * If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound. * Hydrogels can also be used if the wound is in need of moisture. * For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration. A secondary dressing may be desired to add either loft or cushion.
Sponsors
LifeNet Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment; * If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days; * Have a DFU that has been present for at least 30 days or have a VSU that has been present for at least 60 days;
Exclusion criteria
* Have a DFU or VSU that is infected; * Are pregnant or lactating; * Have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin; * Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol; * Have had a HbA1c level greater than 12% within the past 90 days; * Have liver function tests or kidney function tests that are very elevated; * Have a known or suspected disease of the immune system; * Have had surgery in the past 30 days to increase blood flow into your leg or foot; * Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis); * Have undergone wound healing treatment with a living skin equivalent (i.e., Dermagraft®, Apligraf®, TheraSkin®, Oasis®, GraftJacket®, Integra®, Alloderm®) or topical growth factors in the last 4 weeks; * Have active Charcot disease, a weakening of the bones in the foot that can occur in people who have significant nerve damage (neuropathy);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed. | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (AE), changes in vital signs, ankle-brachial index (ABI) and physical examination findings. | 24 weeks | Safety of the interventions will be measured by the incidence of treatment-emergent AEs, changes in vital signs, ABI and physical examination. |
Countries
United States
Outcome results
None listed