Clinical Trial Using the Proteolytic Fraction P1G10 From V. Cundinamarcensis to Heal Diabetic Foot Ulcer

• Status: Completed
• Trial end date: 2016-10-15
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study was to investigate the role of the proteolytic fraction from Vasconcellea cundinamarcensis, designated as P1G10, on healing of chronic foot ulcers in neuropathic patients diagnosed with diabetes type 2. Fifty patients were enrolled in a prospective, randomized, double-blind trial, to verify the efficacy and safety of a topical dressing containing 0.1% P1G10, versus a Hydrogel (positive control) protocol currently applied at the Health Center to treat this condition. Upon completion of the intervention, the outcome evaluated the number of patients attaining full epithelization (100%), or at least 80% healing in both arms (P1G10 versus Hydrogel). Statistical analysis compared the endpoint data on each group to assess the significance of differences.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carlos E Salas

Criteria

Inclusion Criteria:

• Clinical diagnosis of diabetes 2 had

• Hemoglobin ≥ 9.0 g/dl

• total leukocytes ≥ 300/ mm3

• platelets ≥ 100.00/mm3

• total bilirubin ≤ 1.0 mg/dL

• aspartate aminotransferase between 14 and 17 U/L in males and 10 and 33 U/L in females

• pyruvate transaminase between 10 and 40 U/L in males and 7 and 35 U/L in females

• creatinine between 0.70 and 1.20 mg/dL in males and 0.6 and 1.0 mg/dL in females

Exclusion criteria

• pregnant females

• lactating mothers

• highly exuding ulcers

• patients receiving alternative treatments for ulcers

• reported allergy to the components included in the formulation,

• concomitant uncontrolled morbidity

• current active infections,

• HIV serum positives

• diagnosed with neoplasia or undergoing treatment with a cytostatic, or immunosuppressing agent

• individuals subjected to radiotherapy within the last 3 months before beginning the trial.