A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Drug: BioChaperone PDGF-BBOther: Standard of Care
- Registration Number
- NCT02236793
- Lead Sponsor
- Adocia
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BioChaperone PDGF-BB 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 Standard of Care Standard of Care Normal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care
- Primary Outcome Measures
Name Time Method Incidence of complete wound closure. 20 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (32)
Dr Jivraj Mehta Smarak Health Foundation
🇮🇳Ahmedabad, India
IPGME & R and SSKM Hospital
🇮🇳Kolkata, India
V.S. General Hospital & Sml NHL Municipal Medical College Sheth
🇮🇳Ahmedabad, India
Rajiv Gandhi Centre for Diabetes and Endocrinology
🇮🇳Aligarh, India
The Madras Diabetes Research Foundation
🇮🇳Chennai, India
The Madras Medical Mission
🇮🇳Chennai, India
Gandhi Medical College & Hospital
🇮🇳Hyderabad, India
Seth G.S. Medical College and K.E.M Hospital
🇮🇳Mumbai, India
Inamdar Multispeciality Hospital
🇮🇳Pune, India
Govt Medical College and Hospital
🇮🇳Chandigarh, India
Sri Ramachandra Medial Centre
🇮🇳Chennai, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabad, India
Surakshaka diabetic Centre(P) Ltd
🇮🇳Hyderabad, India
Nightingale Hospital
🇮🇳Kolkata, India
Mysore Medical College & Research Institute
🇮🇳Mysore, India
B.J. Govt. Medical College and Sassoon Hospital
🇮🇳Pune, India
Sumana Hospital
🇮🇳Hyderabad, India
SMS Medical College & Attached Hospital
🇮🇳Jaipur, India
SL Raheja Hospital
🇮🇳Mumbai, Maharashtra, India
M.V. Hospital for Diabetes (P) Ltd
🇮🇳Chennai, Tamilnadu, India
Mediciti Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre
🇮🇳Chennai, Taminadu, India
Sangini Hospital
🇮🇳Ahmedabad, India
B.J. Medical College and Civil Hospital
🇮🇳Ahmedabad, India
ILS Hospital
🇮🇳Kolkata, India
Poona Hospital & Research Centre
🇮🇳Pune, India
Rabindranath Tagore International Insitute of cardiac Sciences
🇮🇳Kolkata, India
Fortis Hospital Phase
🇮🇳Mohali, India
Govt Medical college & Hospital Medical Square
🇮🇳Nagpur, India
Indira Gandhi Govt Medical College and Hospital
🇮🇳Nagpur, India
Shree Giriraj Multispeciality Hospital
🇮🇳Rajkot, India
King Georges Hospital
🇮🇳Vishakapatnam, India