A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
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
1 other identifier
interventional
252
1 country
32
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2014
32 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
September 9, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJune 29, 2017
June 1, 2017
1.7 years
September 9, 2014
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of complete wound closure.
20 weeks
Secondary Outcomes (5)
Time to achieve complete wound closure.
20 weeks
Percentage reduction in total ulcer surface area at each visit.
20 weeks
Incidence of complete wound healing
10 weeks
Number of ulcer recurrence observed 12 weeks after wound healing.
32 weeks
Treatment emergent adverse events.
52 weeks
Study Arms (2)
BioChaperone PDGF-BB
EXPERIMENTALBioChaperone PDGF-BB administered every other day at the dose of 4µg/cm² for 20 weeks or until wound closure, associated with Standard of Care
Standard of Care
PLACEBO COMPARATORNormal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adocialead
- Virchow Groupcollaborator
Study Sites (32)
Mediciti Hospital
Hyderabad, Andhra Pradesh, 500 063, India
SL Raheja Hospital
Mumbai, Maharashtra, 400 016, India
M.V. Hospital for Diabetes (P) Ltd
Chennai, Tamil Nadu, India
Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre
Chennai, Taminadu, 600 029, 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
Ahmedabad, India
Rajiv Gandhi Centre for Diabetes and Endocrinology
Aligarh, India
Govt Medical College and Hospital
Chandigarh, India
Sri Ramachandra Medial Centre
Chennai, India
The Madras Diabetes Research Foundation
Chennai, India
The Madras Medical Mission
Chennai, India
Gandhi Medical College & Hospital
Hyderabad, India
Nizam's Institute of Medical Sciences
Hyderabad, India
Sumana Hospital
Hyderabad, India
Surakshaka diabetic Centre(P) Ltd
Hyderabad, India
SMS Medical College & Attached Hospital
Jaipur, India
ILS Hospital
Kolkata, India
IPGME & R and SSKM Hospital
Kolkata, India
Nightingale Hospital
Kolkata, India
Rabindranath Tagore International Insitute of cardiac Sciences
Kolkata, India
Fortis Hospital Phase
Mohali, India
Seth G.S. Medical College and K.E.M Hospital
Mumbai, India
Mysore Medical College & Research Institute
Mysore, India
Govt Medical college & Hospital Medical Square
Nagpur, India
Indira Gandhi Govt Medical College and Hospital
Nagpur, India
B.J. Govt. Medical College and Sassoon Hospital
Pune, India
Inamdar Multispeciality Hospital
Pune, India
Poona Hospital & Research Centre
Pune, India
Shree Giriraj Multispeciality Hospital
Rajkot, India
King Georges Hospital
Visakhapatnam, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arun Bal, MD
SL Raheja Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2014
First Posted
September 11, 2014
Study Start
December 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
June 29, 2017
Record last verified: 2017-06