Status:
COMPLETED
Clinical Trial for the Treatment of Diabetic Foot Ulcers Using a Nitric Oxide Releasing Patch: PATHON
Lead Sponsor:
Fundación Cardiovascular de Colombia
Collaborating Sponsors:
Fundación Santandereana de Diabetes y Obesidad (FUSANDE)
The University of Akron
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 com...
Detailed Description
Background Diabetes Mellitus (DM) constitutes one of the most important public health problems with a worldwide impact due to its high prevalence and enormous social and economic consequences. It is ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00428727
Start Date
January 1 2005
End Date
February 1 2011
Last Update
November 6 2012
Active Locations (1)
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1
Fundacion Cardiovascular de Colombia
Bucaramanga, Santander Department, Colombia