Diabetic FootPhase 2P1G10NCT03700580
Clinical Trial Using the Proteolytic Fraction P1G10 From V. Cundinamarcensis to Heal Diabetic Foot Ulcer
A Phase 2 study testing Hydrogel treatment and P1G10 in people with Diabetic Foot and Neuropathy, Diabetic, run by Carlos E Salas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Neuropathy, Diabetic, Foot Ulcer
- What is being tested?
- Hydrogel treatment and P1G10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2012to 15 Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot, Neuropathy, Diabetic, Foot Ulcer
- Being tested
- Hydrogel treatment, P1G10
- Keywords
- diabetes type 2, wound healing, peripheral neuropathy, P1G10
- Medical subject headings
- Diabetic Foot, Diabetic Neuropathies, Foot Ulcer, Diabetes Mellitus, Type 2, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel treatmentDrug
Also called Gel Comfeel ®, Coloplast, Hydrogel Purilon ®
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.
P1G10Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: P1G10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start15 Aug 2012
- Primary completion14 Oct 2016
- Study completion15 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos E Salas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carlos E Salas, Federal University of Minas Gerais
- Investigators
- Miriam T Lopes, PhD, Study director, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700580
- Sponsor's protocol ID
- P1G10
- Acronym
- P1G10
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28988012Tonaco 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.
PubMed 29564750
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03700580
- Acronym / sponsor ID
- P1G10 / P1G10
- Conditions
- Diabetic Foot, Neuropathy, Diabetic, Foot Ulcer
- Keywords
- diabetes type 2, wound healing, peripheral neuropathy, P1G10
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Carlos E SalasUniversity, hospital or other
- Study start
- 15 Aug 2012 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 15 Oct 2016 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hydrogel treatment | Active comparator | Drug: Hydrogel treatmentIt 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. |
| P1G10 treatment | Experimental | Drug: P1G10It 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- pregnant females
- lactating mothers
- highly exuding ulcers
- patients receiving alternative treatments for ulcers
- reported allergy to the components included in the formulation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogel treatmentAlso: Gel Comfeel ®, Coloplast, Hydrogel Purilon ®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 | Hydrogel treatment |
| P1G10P1G10 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. | Drug | P1G10 treatment |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 28988012Freitas 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.
- Results publication: PubMed 29564750Tonaco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam T Lopes, PhD study director
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrogel treatment and P1G10 in people with Diabetic Foot and Neuropathy, Diabetic, run by Carlos E Salas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700580, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.