A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

June 28, 2017 updated by: Adocia

Phase III, Multicentre, Randomized, Parallel Group, Double Blinded and Control Group Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 3

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

      • Ahmedabad, India
        • B.J. Medical College and Civil Hospital
      • Ahmedabad, India
        • Dr Jivraj Mehta Smarak Health Foundation
      • Ahmedabad, India
        • Sangini Hospital
      • Ahmedabad, India
        • V.S. General Hospital & Sml NHL Municipal Medical College Sheth
      • Aligarh, India
        • Rajiv Gandhi Centre for Diabetes and Endocrinology
      • Chandigarh, India
        • Govt Medical College and Hospital
      • Chennai, India
        • Sri Ramachandra Medial Centre
      • Chennai, India
        • The Madras Diabetes Research Foundation
      • Chennai, India
        • The Madras Medical Mission
      • Hyderabad, India
        • Gandhi Medical College & Hospital
      • Hyderabad, India
        • NIZAM'S Institute of Medical Sciences
      • Hyderabad, India
        • Sumana Hospital
      • Hyderabad, India
        • Surakshaka diabetic Centre(P) Ltd
      • Jaipur, India
        • SMS Medical College & Attached Hospital
      • Kolkata, India
        • ILS Hospital
      • Kolkata, India
        • IPGME & R and SSKM Hospital
      • Kolkata, India
        • Nightingale Hospital
      • Kolkata, India
        • Rabindranath Tagore International Insitute of cardiac Sciences
      • Mohali, India
        • Fortis Hospital Phase
      • Mumbai, India
        • Seth G.S. Medical College and K.E.M Hospital
      • Mysore, India
        • Mysore Medical College & Research Institute
      • Nagpur, India
        • Govt Medical college & Hospital Medical Square
      • Nagpur, India
        • Indira Gandhi Govt Medical College and Hospital
      • Pune, India
        • B.J. Govt. Medical College and Sassoon Hospital
      • Pune, India
        • Inamdar Multispeciality Hospital
      • Pune, India
        • Poona Hospital & Research Centre
      • Rajkot, India
        • Shree Giriraj Multispeciality Hospital
      • Vishakapatnam, India
        • King Georges Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 063
        • Mediciti Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 016
        • SL Raheja Hospital
    • Tamilnadu
      • Chennai, Tamilnadu, India
        • M.V. Hospital for Diabetes (P) Ltd
    • Taminadu
      • Chennai, Taminadu, India, 600 029
        • Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre

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:

  • Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus
  • Patient with a single ulcer on the treated feet
  • Patient able and willing to provide informed consent
  • Patient able and willing to comply with protocol visits and procedure
  • Patient willing to use an off-loading method during the whole duration of the study
  • Full-thickness plantar, lateral or dorsal ulcer of the extremity (below the malleolus), excluding inter-digits ulcer (web spaces), 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 or Grade 1 according to Wagner classification)
  • Chronic ulcer of at least six weeks despite appropriate wound care
  • Ulcer area measured with the formula Length x Width x 0.8 following sharp debridement, of 1 to 10 cm², both inclusive
  • Well controlled infection or cellulitis (systemic antibiotherapy) before Baseline Visit
  • Peripheral neuropathy as assessed by Semmes- Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
  • Ankle brachial pressure index > 0.60 and <1.3
  • Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing

Exclusion Criteria:

  • Inter digit ulcers
  • Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers
  • Charcot foot.
  • Wound originated from amputation bed
  • Active ulcer infection assessed by clinical examination and radiography if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement and controlled by standard wound care.
  • Active osteomyelitis affecting the area of the target ulcer
  • Poorly controlled diabetes (uncontrolled glycemia: HbA1c% >= 10%), 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 or growth factor within 30 days
  • Topical application of any advance wound care on this wound (antiseptics, antibiotics, debriders, enzyme) 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.
  • A history of severe cerebrovascular events

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
Experimental: BioChaperone PDGF-BB
BioChaperone PDGF-BB administered every other day at the dose of 4µg/cm² for 20 weeks or until wound closure, associated with Standard of Care
Placebo Comparator: Standard of Care
Normal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of complete wound closure.
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to achieve complete wound closure.
Time Frame: 20 weeks
20 weeks
Percentage reduction in total ulcer surface area at each visit.
Time Frame: 20 weeks
20 weeks
Incidence of complete wound healing
Time Frame: 10 weeks
10 weeks
Number of ulcer recurrence observed 12 weeks after wound healing.
Time Frame: 32 weeks
32 weeks
Treatment emergent adverse events.
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

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

Sponsor

Collaborators

Investigators

  • Principal Investigator: Arun Bal, MD, SL Raheja Hospital

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)

December 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

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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