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:
Participant gender:
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.