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

NCT03700580 | Completed Phase 2

• 1 other identifier: P1G10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot; Neuropathy, Diabetic; Foot Ulcer

Keywords

diabetes type 2; wound healing; peripheral neuropathy; P1G10

Outcome Measures

Primary Outcomes (1)

• 100% epithelization

  A primary end point was considered as full re-epithelization (100%) of the injury assessed by presence of epithelial tissue in 100% of the bed occurring during, or at the end of 48 applications. Quantification of healing is assessed by measure of the wound area, registered with Sony camera (Cyber-shot), 18.2 megapixels. Along the ulcer is positioned a standard mold (5.1 x 15.0) cm including proband's initials, record number and date of treatment. A transparent sterile paper superimposed on the wound, measured the orthogonal lengths to estimate the wound area. Normal distribution of data was evaluated with Shapiro-Wilk test. The differences in values between groups were assessed by t- test. Wound healing incidence was expressed as 1000 person-day with 95% confidence interval in both groups. To minimize the effect of noncompliance and missing outcomes, the data were analyzed as "intention to treat" thus including every subject enrolled in each group during the initial assignment.

  The primary outcome (100% epithelization) is measured at the time of the intervention (1-16 weeks). If this endpoint is attained at a given date, the interval between the first intervention and the endpoint date is the period scored for the event.

Secondary Outcomes (1)

• 80% epithelization

  The secondary outcome (80% epithelization) is measured at the time of the intervention (1-16 weeks). If this endpoint is attained at a given date, the interval between the first intervention and the endpoint date is the period scored for the event.

Study Arms (2)

Hydrogel treatment

ACTIVE COMPARATOR

It refers to the standard treatment currently applied for foot ulcers at the Health Center where the study was conducted. The intervention was applied to the cohort, three times a week during 16 weeks or when the wound attained full epithelization. The wound bed was cleaned with physiological serum before application of Hydrogel.

Drug: Hydrogel treatment

P1G10 treatment

EXPERIMENTAL

It refers to the experimental parallel intervention consisting of three weekly applications of 0.1% P1G10 dispersed in the hydrosoluble vehicle during a 16-week period, or until full epithelization of the wound. The wound bed was cleaned with physiological serum before application of the drug.

Drug: P1G10

Interventions

Hydrogel treatment DRUG

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.

Also known as: Gel Comfeel ®, Coloplast, Hydrogel Purilon ®

Hydrogel treatment

P1G10 DRUG

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.

P1G10 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos E Salas: lead

Study Sites (1)

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

Belo Horizonte, Minas Gerais, 30720-100, Brazil

Location

Related Publications (2)

• Freitas KM, Barcelos LS, Caliari MV, Salas CE, Lopes MTP. Healing activity of proteolytic fraction (P1G10) from Vasconcellea cundinamarcensis in a cutaneous wound excision model. Biomed Pharmacother. 2017 Dec;96:269-278. doi: 10.1016/j.biopha.2017.09.109. Epub 2017 Oct 6.

  PMID: 28988012 BACKGROUND

• Tonaco LAB, Gomes FL, Velasquez-Melendez G, Lopes MTP, Salas CE. The Proteolytic Fraction from Latex of Vasconcellea cundinamarcensis (P1G10) Enhances Wound Healing of Diabetic Foot Ulcers: A Double-Blind Randomized Pilot Study. Adv Ther. 2018 Apr;35(4):494-502. doi: 10.1007/s12325-018-0684-2. Epub 2018 Mar 21.

  PMID: 29564750 RESULT

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies; Foot Ulcer; Diabetes Mellitus, Type 2; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Foot Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Miriam T Lopes, PhD

  Federal University of Minas Gerais

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Biochemistry

Model Details: The intervention encompassed a topical application on the ulcer bed of the active fraction 0.1% P1G10 dispersed in hydrosoluble vehicle. The control group received hydrogel with the same frequency adopted for P1G10 (Three times per week during 16 weeks). Regardless the intervention prior to each application the ulcer bed was cleaned with 0.9% physiological serum without antiseptic.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: August 15, 2012
• Primary Completion: October 14, 2016
• Study Completion: October 15, 2016
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

BR (1)