Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098357
• Other study ID #: BC1-CT1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 1, 2010
• Last updated: December 12, 2014
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: Virchow Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Description:

After the screening visit, the eligible patient population randomly receive one of the three following topical drugs:

• BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,

• BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or

• BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or

• Beclapermin gel 6.25 µg/cm²/application for 20 weeks.

The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study. The maximum number of visits expected is 16. The study data is presented at the end of 20 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Drug:
• Biochaperone PDGF-BB Low dose
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
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
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
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

Locations

Country	Name	City	State
India	Jain Institute of Vascular sciences	Bangalore	Karnataka
India	Karnataka Institute of Diabetology	Bangalore	Karnataka
India	M.V. Hospital for Diabetes	Chennai	Tamilnadu
India	Lakeshore Hospital & Research Centre Ltd	Kochi	Kerela
India	S.K. Diabetes Research & Education Centre	Kolkata	West Bengal
India	Joshi Hospital , Maharashra Medical Foundation	Pune	Maharashtra
India	Vijay Vachharajani Memorial	Rajkot	Gujarat

Sponsors (2)

Lead Sponsor	Collaborator
Virchow Group	Adocia

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete wound closure	Incidence of complete wound closure	20 WEEKS	No
Secondary	Time to achieve complete wound closure	Time to achieve complete wound closure	Study duration 20 weeks	No
Secondary	Percentage reduction in total ulcer surface area at each visit.		Study duration 20 weeks	No
Secondary	Incidence of complete wound healing at week 10		10 weeks	No
Secondary	Safety Safety Measures	Treatment emergent adverse events with investigator's assessment of seriousness, severity, duration and relationship to study medication; Wound-related infections; Changes in standard laboratory tests (hematology, biochemistry and detection of antibodies)	Study duration 20 weeks	Yes