Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
A Phase I/II, Multicentre, Randomised, Controlled, and Open-label Trial Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
1 other identifier
interventional
192
1 country
7
Brief Summary
This is an open-label, active-control, multicentre, parallel group, randomised and dose-finding efficacy and safety study. Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks for the treatment of neuropathic diabetic foot ulcer. Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days for up to 20 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2010
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 15, 2014
August 1, 2012
8 months
April 1, 2010
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of complete wound closure
Incidence of complete wound closure
20 WEEKS
Secondary Outcomes (4)
Time to achieve complete wound closure
Study duration 20 weeks
Percentage reduction in total ulcer surface area at each visit.
Study duration 20 weeks
Incidence of complete wound healing at week 10
10 weeks
Safety Safety Measures
Study duration 20 weeks
Study Arms (4)
Biochaperone PDGF-BB low dose
EXPERIMENTALBioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial.
Biochaperone PDGF-BB High dose
EXPERIMENTALBioChaperone PDGF-BB is a new formulation of the B isoform dimer of recombinant human Platelet-Derived Growth Factor (rhPDGF-BB) containing the new excipient Biochaperone, a dextran modified polymer. The finished product is a sterile multi-dose spray vial.
Regranex
ACTIVE COMPARATORBecaplermin gel (Regranex® Gel 0.01%, Systagenix, formerly and Johnson \& Johnson) is a topical gel of rhPDGF-BB conditioned in a gel tube.
Very Low Dose BioChaperone PDGF-BB
EXPERIMENTALBioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
Interventions
BioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks
BioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks
Regranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks
BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
Eligibility Criteria
You may qualify if:
- Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
- Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification).
- Chronic ulcer of at least six weeks despite appropriate wound care.
- Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
- Well controlled infection or cellulitis (systemic antibiotherapy).
- Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
- Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index \> 0.60, or ankle systolic pressure \> 70 mmHg or toe pressure \> 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
- Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing.
- Signed informed consent before any study procedure.
You may not qualify if:
- Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
- Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
- Active osteomyelitis affecting the area of the target ulcer.
- Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine \> 3.0 mg/dL), poor nutritional status (albumin \< 3.0 g/dL or total protein \< 6.5 g/dL).
- Known connective tissue or malignant disease.
- Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
- Use of investigational drug/device within 30 days.
- Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days.
- Vascular reconstruction within 8 weeks. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virchow Grouplead
- Adociacollaborator
Study Sites (7)
Vijay Vachharajani Memorial
Rajkot, Gujarat, India
Jain Institute of Vascular sciences
Bangalore, Karnataka, 560052, India
Karnataka Institute of Diabetology
Bangalore, Karnataka, 560069, India
Lakeshore Hospital & Research Centre Ltd
Kochi, Kerala, 682 040, India
Joshi Hospital , Maharashra Medical Foundation
Pune, Maharashtra, India
M.V. Hospital for Diabetes
Chennai, Tamil Nadu, 600013, India
S.K. Diabetes Research & Education Centre
Kolkata, West Bengal, 700 009, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
T C Raghuram, MD, Phd
Medical Director
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 2, 2010
Study Start
June 1, 2010
Primary Completion
February 1, 2011
Study Completion
September 1, 2011
Last Updated
December 15, 2014
Record last verified: 2012-08