Efficacy and Safety Study of DERMAGEN® vs Conventional Treatment to Treat Diabetic Neuropathic Foot Ulcer
Recruitment status was Active, not recruiting
It is estimated that 300 million people worldwide will have diabetes by the year 2025. About 12 percent of those with diabetes will have had a foot ulcer, which is a major source of morbidity, concern, and cost.
The foot ulcers are the leading cause of hospitalization among people with diabetes and often lead to amputation. The costs of treatment and the high morbidity and mortality associated with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer management.
Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and growth factors. However modern dressings may not avoid infection and the results of the clinical studies are not significant in terms of complete healing rate or in terms of time to healing. Concerning growth factors, the only one whose therapeutic application made proof is the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the twentieth week compared to placebo (50% and 35%, respectively).
The advancement of tissue-engineering has made possible dermal replacement on human wounds to facilitate healing.
A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate), reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds), biocompatible and biodegradable processes, handling and storable easily.
The objective of this study is to demonstrate that such a substitute, cellularized by functional allogenic fibroblasts, and complying with all safety conditions, enables to lead to healing of diabetic foot ulcers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomised, Multi-centre, Blind-observer, Controlled, Parallel-group Study Comparing the Efficacy and Safety of DERMAGEN® Versus Conventional Treatment in the Treatment of Diabetic Neuropathic Foot Ulcer|
- Complete wound closure at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Time to complete wound healing [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Weekly topical applications
Active Comparator: B
Weekly topical applications
|Study Chair:||Olivier Chosidow, MD, PhD||Hôpital Tenon, Paris|