Clinical Trial for the Treatment of Diabetic Foot Ulcers Using a Nitric Oxide Releasing Patch: PATHON
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
Diabetes Mellitus constitutes one of the most important public health problems due to its
high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one
of the chronic complications of diabetes mellitus and constitute the most important cause of
non-traumatic amputation of inferior limbs. It is estimated that 15% of diabetic population
will develop an ulcer sometime in their life. Although novel therapies have been proposed,
there is no effective treatment for this pathology. Naturally produced nitric oxide
participates in the wound healing process by stimulating the synthesis of collagen,
triggering the release of chemotactic cytokines, increasing blood vessels permeability,
promoting angiogenic activity, stimulating the release of epidermal growth factors, and by
interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric
oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary
to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical
donors needed to be applied frequently, diminishing the adherence to the treatment. This
difficulty has led to the development of a multilayer polymeric transdermal patch produced by
electrospinning technique that guarantees a constant nitric oxide release. The main objective
of this study is to evaluate the effectiveness and safety of this novel nitric oxide
releasing wound dressing for the treatment of diabetic foot ulcers.
A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was
designed. At the time of enrollment, a complete medical evaluation and laboratory tests will
be performed, and those patients who meet the inclusion criteria randomly assigned to one of
two groups. During 90 days group 1 will receive active patches and group 2 placebo patches.
The patients will be seen by the research group at least every two weeks until the healing of
the ulcer or the end of the treatment. During each visit the healing process of the ulcer,
the patient's health status and the presence of adverse events will be assessed. Should the
effectiveness of the patches be demonstrated an alternative treatment would then be available
to patients.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación Cardiovascular de Colombia
Collaborators:
Fundación Santandereana de Diabetes y Obesidad (FUSANDE) Instituto de Salud de Bucaramanga The University of Akron Universidad de Santander