A Phase 4 interventional study of DermaPure™ and Standard care in Diabetic Foot Ulcers, sponsored by TRx Wound Care Limited. Status unknown at 7 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-11-05.
Sponsored by TRx Wound Care Limited · Phase 4, Interventional, and Treatment
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.
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.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with TRx Wound Care Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DermaPure™ in combination with standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear.
Other: DermaPure™
Standard care comprising surgical debridement, covered by a non-adherent silicone wound contact layer, a wound cavity filler (if required), a secondary foam wound dressing and appropriate off-loading footwear.
Other: Standard care
A minimally manipulated human tissue regulated as "human cells, tissues, and cellular and tissue-based products" (HCT/Ps)
Incidence of wound closure
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".
Time frame: 12 weeks
Rate of wound healing
Percentage reduction in ulcer area and volume, weekly up to Week 12 compared to baseline.
Time frame: 12 weeks
Quality of wound healing
Cellular profile through histological analysis of wound biopsies at Week 4 compared to baseline
Time frame: 4 weeks
Rate of wound healing in crossover arm
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).
Time frame: 6 weeks
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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