Diabetes Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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