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

October 8, 2018 updated by: Carlos E Salas

Application of a Double Blind Clinical Trial Protocol for Evaluation of Healing Action of P1G10, From V Cundinamarcensis to Chronic Neuropathic Wounds in Diabetic Foot Ulcers.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteers admitted for the study were randomly assigned into two distinct treatment groups. Randomization was performed by simple and stratified draw for each type of treatment. The treatment options were: a) Hydrogel™ and b) P1G10. The active principle had been previously dissolved in water and dispersed into Polawax dressing at 0.1% w/w final. Polawax™ is an emulsifying wax for cosmetic preparations. According to the manufacturers, it is able to hold together all types of ingredients without residue or separation. It is, therefore, ideal for "oil in water" creams and lotions. Number were used to identify both formulations.

The staff participating in this clinical trial, including researchers was unaware of the identity of the formulation applied on each proband. Each formulation used during the intervention was dispensed weekly at the Laboratory of Antitumor Substances of the Institute of Biological Sciences of the Federal University of Minas Gerais by members of the research group who had no contact with the staff responsible for the application of the protocol. The formulations were stored at 4°C until its application.

The treatment and the collection of data, took place between August 2012 and October 2016, and it was carried out by health professional and a technical assistant previously trained to evaluate and perform the procedure.

The application of the intervention was done three times per week (Monday, Wednesday and Friday), completing 48 applications or until full epithelialization of the ulcer was observed, whichever occurred first. The treatment was performed exclusively at the outpatient level. When the proband could not attend the scheduled treatment, he (she) was instructed to perform the dressing change only with 0.9% saline solution. Patients who missed two consecutive scheduled interventions were withdrawn from the study.

Ulcers were cleaned with 0.9% physiological solution using soft pressure, without scrubbing or addition of antiseptic substances. Subsequently, a thin layer of the ointment containing P1G10 or Hydrogel was applied over the ulcer bed, covering all its extension. Then double gauze was applied, fixed with adhesive tape and crepe bandage, if necessary. In cases of users with more than one wound, each wound received identical treatment, but only one ulcer was selected for the study.

During the first week of treatment, the subjects were observed for 30 minutes after the intervention, in order to verify possible undesirable effects. After this interval, if they did not present adverse events, they were released. Users were also instructed to contact the responsible investigators by telephone if they observed the emergence of any adverse effects. A prior trial of the formulation containing 0.1% P1G10 applied onto the arm of healthy individuals during one-month did not induce local or systemic affects.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30720-100
        • Unidade de Referência Secundária (URS) Padre Eustáquio, do Distrito Sanitário Noroeste da Secretaria Municipal e Saúde de Belo Horizonte.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hydrogel treatment
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
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.
Other Names:
  • Gel Comfeel ®
  • Coloplast
  • Hydrogel Purilon ®
Experimental: P1G10 treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100% epithelization
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
80% epithelization
Time Frame: 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.
A secondary end point was considered as 80% re-epithelization of the injury assessed by presence of epithelial tissue in 80% 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 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos E Salas

Investigators

  • Study Director: Miriam T Lopes, PhD, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2012

Primary Completion (Actual)

October 14, 2016

Study Completion (Actual)

October 15, 2016

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 7, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1G10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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