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

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 15, 2012

Primary Completion Date

October 14, 2016

Study Completion Date

October 15, 2016

Conditions
Diabetic FootNeuropathy, DiabeticFoot Ulcer
Interventions
DRUG

Hydrogel treatment

Hydrogel dressing containing water, carboxymethyl cellulose and sodium alginate in non-specified proportions, purchased in bulk amounts was sterile dispensed in smaller amounts (200 g) for frequent use.

DRUG

P1G10

P1G10 containing dressing composed by 8% Polawax, 6% liquid vaseline, 0.06% butylated hydroxytoluene, 0.15% Nipagin, 5% propyleneglycol, 0.1% Nipazol, 0.1% ethylenediaminetetraacetate disodium salt, 0.03% methyl-aminopropanol-95, 0.3% Imidazolidinyl urea, 2% Cyclomethicone, 78.2% distilled water. A single batch of the formulation was made and used throughout the intervention. A sample of this preparation was used to assess the extended stability of the formulation. The formulation was dispensed into 100 g dispensers for weekly use.

Trial Locations (1)

30720-100

Unidade de Referência Secundária (URS) Padre Eustáquio, do Distrito Sanitário Noroeste da Secretaria Municipal e Saúde de Belo Horizonte., Belo Horizonte

All Listed Sponsors
lead

Carlos E Salas

OTHER

NCT03700580 - Clinical Trial Using the Proteolytic Fraction P1G10 From V. Cundinamarcensis to Heal Diabetic Foot Ulcer | Biotech Hunter | Biotech Hunter