A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02081352
Study type	Interventional
Source	TRx Wound Care Limited
Contact	sheila nicholson
Phone	+44 3304303066
Email	s.nicholson@tissueregenix.com
Status	Recruiting
Phase	Phase 4
Start date	August 2014
Completion date	February 2017

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00013286` - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk	Phase 2
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Not yet recruiting	`NCT00916292` - Safety Study of Topical Human FGF-1 for Wound Healing	Phase 1
Completed	`NCT01154374` - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)	Phase 2
Not yet recruiting	`NCT02672280` - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects	Phase 1/Phase 2