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

Launched by FUNDACIÓN CARDIOVASCULAR DE COLOMBIA · Jan 26, 2007

Keywords

ClinConnect Summary

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 believed that there are more than 135 million diabetics, and this number is expected to increase to 300 million in the next 25 years (30% in developed and 70% in developing countries) \[1;2\].

This epidemic is related to several factors like ethnicity, the longer life expectancy, and the epidemiological and nutritional transition in developing countries due to the urbanization process that bri...

Gender

ALL

Eligibility 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 ≤2.
• • 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.