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

NCT00428727 | Completed Phase 3 DMC

• 1 other identifier: fcv075
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic foot; Ulcer; nitric oxide; treatment; donor; controlled trial

Outcome Measures

Primary Outcomes (1)

• Ulcer reduction percentage

  90 days after beggining the treatment

Secondary Outcomes (3)

• Complete cure of the infection that was present before the treatment.

  during 90 days of treatment

• Infection of the ulcers during the treatment.

  during 90 days of treatment

• Presence of adverse events related to the application of the patches

  during 90 days of treatment

Study Arms (2)

1

EXPERIMENTAL

Nitric oxide patches

Drug: Controlled nitric oxide releasing patch

2

PLACEBO COMPARATOR

Placebo patches

Drug: placebo patch

Interventions

Controlled nitric oxide releasing patch DRUG

daily application of nitric oxide patch during 90 days

1

placebo patch DRUG

daily application during 90 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Fundación Santandereana de Diabetes y Obesidad (FUSANDE): collaborator
• The University of Akron: collaborator
• Universidad de Santander: collaborator
• Instituto de Salud de Bucaramanga: collaborator

Study Sites (1)

Fundacion Cardiovascular de Colombia

Bucaramanga, Santander Department, Colombia

Location

Related Publications (1)

• Silva SY, Rueda LC, Marquez GA, Lopez M, Smith DJ, Calderon CA, Castillo JC, Matute J, Rueda-Clausen CF, Orduz A, Silva FA, Kampeerapappun P, Bhide M, Lopez-Jaramillo P. Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch: PATHON. Trials. 2007 Sep 26;8:26. doi: 10.1186/1745-6215-8-26.

  PMID: 17897470 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricio López-Jaramillo, MD, PhD

  Fundacion Cardiovascular de Colombia

  PRINCIPAL INVESTIGATOR

• Daniel J Smith, PhD

  The University of Akron

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 30, 2007
• Study Start: January 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 6, 2012

Record last verified: 2012-11

Locations

CO (1)