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Sponsors and Collaborators: |
Fundación Cardiovascular de Colombia Fundación Santandereana de Diabetes y Obesidad (FUSANDE) The University of Akron University of Santander Instituto de Salud de Bucaramanga (ISABU) |
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Information provided by: | Fundación Cardiovascular de Colombia |
ClinicalTrials.gov Identifier: | NCT00428727 |
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.
Condition | Intervention | Phase |
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Diabetic Foot |
Drug: Controlled nitric oxide releasing patch Drug: placebo patch |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double Blind, Randomized, Placebo Controlled Clinical Trial for the Treatment of Diabetic Foot Ulcers, Using a Nitric Oxide Releasing Patch: PATHON |
Estimated Enrollment: | 100 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Controlled nitric oxide releasing patch
daily application of nitric oxide patch during 90 days
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2: Placebo Comparator |
Drug: placebo patch
daily application during 90 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patricio López-Jaramillo, MD, PhD | +57-7-639292 ext 331 | joselopez@fcv.org |
Colombia, Santander | |
Fundacion Cardiovascular de Colombia | Recruiting |
Bucaramanga, Santander, Colombia | |
Contact: Patricio López-Jaramillo, MD, PhD +57-7-6396767 ext 331 joselopez@fcv.org |
Principal Investigator: | Patricio López-Jaramillo, MD, PhD | Fundacion Cardiovascular de Colombia |
Principal Investigator: | Daniel J Smith, PhD | The University of Akron |
Study Chair: | Sandra Y Silva, MD | Fundacion Cardiovascular de Colombia |
Study Chair: | Ligia C Rueda, MD | Fundacion Cardiovascular de Colombia |
Study Chair: | Gustavo A Márquez, MD | Fundacion Cardiovascular de Colombia |
Study Chair: | Marcos López, PhD | The University of Akron |
Study Chair: | Piyaporn Kampeerapappun | The University of Akron |
Study Chair: | Juan C Castillo, MD | Fundacion Cardiovascular de Colombia |
Study Chair: | Carlos A Calderon, PhD | Fundación Santandereana de Diabetes y Obesidad |
Study Chair: | Jaime Matute, MD | Instituto de Seguros Sociales |
Study Chair: | Christian F Rueda-Clausen, MD | Fundacion Cardiovascular de Colombia |
Study Chair: | Arturo Orduz, MD | Fundacion Cardiovascular de Colombia |
Study Chair: | Federico A Silva, MD | Fundacion Cardiovascular de Colombia |
Responsible Party: | Fundación Cardiovascular de Colombia ( Victor Raúl Castillo Mantilla ) |
Study ID Numbers: | fcv075 |
Study First Received: | January 26, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00428727 |
Health Authority: | Colombia: Institutional Review Board; United States: Institutional Review Board |
Diabetic foot Ulcer nitric oxide |
treatment donor controlled trial |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Nitric Oxide Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents Protective Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Cardiovascular Diseases Peripheral Nervous System Agents Bronchodilator Agents |