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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Men and women 18 years or older.

• Capacity of attending the visits at the research site.

• Confirmed diagnosis of DM type 1 or 2 according to the guidelines from the American Diabetes Association (ADA).

• Presence of 1 or more DFU, less than 15cm in its biggest diameter, with a Texas University score ≤2.

• Pharmacological treatment for glycemic control.

• Willingness to participate in the study and to sign the informed consent form.

Exclusion Criteria:

• Unconfirmed DM diagnosis.

• Any pathology that, based on the judgment of the researcher, could alter the course of DFU (neoplasias, immunological disorders, etc).

• Renal insufficiency requiring dialysis treatment.

• DFU with a Texas score >2.

• Infected DFU with clinical or paraclinical findings suggesting osteomyelitis.

• Critical ischemia of IL diagnosed by Doppler ultrasound and defined by ankle/arm index < 0.5.

• Clinical findings suggesting complicated venous insufficiency of IL.

• Distal necrosis of the limb with the ulcer.

• Pregnant or breastfeeding women.

• Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

• Refusal to give informed consent.