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

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Clinical Trial for the Treatment of Diabetic Foot Ulcers Using a Nitric Oxide Releasing Patch: PATHON
This study is currently recruiting participants.
Verified by Fundaci¨®n Cardiovascular de Colombia, May 2008
Sponsors and Collaborators: Fundaci¨®n Cardiovascular de Colombia
Fundaci¨®n Santandereana de Diabetes y Obesidad (FUSANDE)
The University of Akron
University of Santander
Instituto de Salud de Bucaramanga (ISABU)

Information provided by: Fundaci¨®n Cardiovascular de Colombia
ClinicalTrials.gov Identifier: NCT00428727

Purpose
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
Diabetic Foot
Drug: Controlled nitric oxide releasing patch
Drug: placebo patch
Phase III

MedlinePlus related topics: Diabetes Diabetic Foot Foot Health
Drug Information available for: Nitric oxide
U.S. FDA Resources
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

Further study details as provided by Fundaci¨®n Cardiovascular de Colombia:

Primary Outcome Measures:
Ulcer reduction percentage [ Time Frame: 90 days after beggining the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Complete cure of the infection that was present before the treatment. [ Time Frame: during 90 days of treatment ] [ Designated as safety issue: No ]

Infection of the ulcers during the treatment. [ Time Frame: during 90 days of treatment ] [ Designated as safety issue: Yes ]

Presence of adverse events related to the application of the patches [ Time Frame: during 90 days of treatment ] [ Designated as safety issue: Yes ]

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
1: Experimental Drug: Controlled nitric oxide releasing patch
daily application of nitric oxide patch during 90 days
2: Placebo Comparator Drug: placebo patch
daily application during 90 days

Eligibility
Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
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 ¡Ü2.
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.
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428727

Contacts
Contact: Patricio L¨®pez-Jaramillo, MD, PhD +57-7-639292 ext 331 joselopez@fcv.org

Locations
Colombia, Santander
Fundacion Cardiovascular de Colombia Recruiting
Bucaramanga, Santander, Colombia
Contact: Patricio L¨®pez-Jaramillo, MD, PhD +57-7-6396767 ext 331 joselopez@fcv.org

Sponsors and Collaborators
Fundaci¨®n Cardiovascular de Colombia
Fundaci¨®n Santandereana de Diabetes y Obesidad (FUSANDE)
The University of Akron
University of Santander
Instituto de Salud de Bucaramanga (ISABU)
Investigators
Principal Investigator: Patricio L¨®pez-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 M¨¢rquez, MD Fundacion Cardiovascular de Colombia
Study Chair: Marcos L¨®pez, 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 Fundaci¨®n 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:Fundaci¨®n Cardiovascular de Colombia ( Victor Ra¨²l Castillo Mantilla )
Study ID Numbers:fcv075
First Received:January 26, 2007
Last Updated:May 20, 2008
ClinicalTrials.gov Identifier:NCT00428727 [history]
Health Authority:Colombia: Institutional Review Board; United States: Institutional Review Board

Keywords provided by Fundaci¨®n Cardiovascular de Colombia:
Diabetic foot
Ulcer
nitric oxide
treatment
donor
controlled trial

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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