Diabetic Foot Ulcers
Conditions
Keywords
Dermis, Diabetic foot ulcers, Skin substitutes, Decellularized
Brief summary
This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.
Detailed description
DermaPure™ is a decellularized dermal skin substitute using the Tissue Regenix dCELL® patented Technology to remove cells and other components from human and animal tissue while maintaining the native structural and biomechanical properties. The primary objective of the study is to establish the wound healing performance and safety of DermaPure™ over a 12 week period, when administered to hard to heal chronic, neuropathic diabetic foot ulcers. This study has been designed to compare the performance of DermaPure™ (in combination with standard care) versus standard care alone.
Interventions
OTHERDermaPure™
A minimally manipulated human tissue regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps)
OTHERStandard care
Sponsors
TRx Wound Care Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or Type 2 diabetes with HbA1c ≤12% * Adequate perfusion * A full thickness chronic, neuropathic diabetic foot plantar ulcer defined by Texas or Wagner classification. * Target ulcer decreases in size (surface area) by less than 30% in the 2 week screening period.
Exclusion criteria
* BMI greater than 45kg/m2. * Presence of infection * Presence of necrosis, purulence or sinus tracts that cannot be removed by aggressive debridement. * A clinical diagnosis of an active/acute Charcot neuroarthropathy. Inactive/chronic Charcot does not exclude the patient. * Therapy with any investigational agent or drug within 4 weeks preceding the screening visit. * More than 2 weeks treatment with immunosuppressive agents within 3 months of enrollment. * Evidence of malnutrition as confirmed by serum pre-albumin level at screening. * Evidence of drug or alcohol abuse,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound closure | 12 weeks | The incidence of full wound closure at or before 12 weeks, where full wound closure is defined as 100% re-epithelialization, without drainage, that has been confirmed at two study visits up to 14 days apart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound healing | 12 weeks | Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline. |
| Quality of wound healing | 4 weeks | Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound healing in crossover arm | 6 weeks | Percentage reduction in ulcer area and volume, weekly up to Week 18 compared to Week 12 for a subset of subjects who receive first application of DermaPure™ at Week 12 (Crossover arm). |
Countries
United States
Contacts
Primary Contactsheila nicholson
Outcome results
None listed