Clinical Trial for the Treatment of Diabetic Foot Ulcers Using a Nitric Oxide Releasing Patch: PATHON

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.

Conditions

• Diabetic Foot

Interventions

DRUG

Controlled nitric oxide releasing patch

daily application of nitric oxide patch during 90 days

DRUG

placebo patch

daily application during 90 days

Sponsors & Collaborators

• Fundación Santandereana de Diabetes y Obesidad (FUSANDE)

  collaborator UNKNOWN

• The University of Akron

  collaborator OTHER

• Universidad de Santander

  collaborator OTHER

• Instituto de Salud de Bucaramanga

  collaborator OTHER

• Fundación Cardiovascular de Colombia

  lead OTHER

Principal Investigators

• Patricio López-Jaramillo, MD, PhD · Fundacion Cardiovascular de Colombia

• Daniel J Smith, PhD · The University of Akron

• Sandra Y Silva, MD · Fundacion Cardiovascular de Colombia

• Ligia C Rueda, MD · Fundacion Cardiovascular de Colombia

• Gustavo A Márquez, MD · Fundacion Cardiovascular de Colombia

• Marcos López, PhD · The University of Akron

• Piyaporn Kampeerapappun · The University of Akron

• Juan C Castillo, MD · Fundacion Cardiovascular de Colombia

• Carlos A Calderon, PhD · Fundación Santandereana de Diabetes y Obesidad

• Jaime Matute, MD · Instituto de Seguros Sociales

• Christian F Rueda-Clausen, MD · Fundacion Cardiovascular de Colombia

• Arturo Orduz, MD · Fundacion Cardiovascular de Colombia

• Federico A Silva, MD · Fundacion Cardiovascular de Colombia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2011-02-28

Completion

2011-02-28

Countries

• Colombia

Study Locations