A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
NCT ID: NCT02236793
Last Updated: 2017-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
252 participants
INTERVENTIONAL
2014-12-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
BioChaperone PDGF-BB
Standard of Care
Normal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care
Standard of Care
Interventions
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BioChaperone PDGF-BB
Standard of Care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Virchow Group
INDUSTRY
Adocia
INDUSTRY
Responsible Party
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Principal Investigators
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Arun Bal, MD
Role: PRINCIPAL_INVESTIGATOR
SL Raheja Hospital
Locations
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Mediciti Hospital
Hyderabad, Andhra Pradesh, India
SL Raheja Hospital
Mumbai, Maharashtra, 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, 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
Countries
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Other Identifiers
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BC1-CT4
Identifier Type: -
Identifier Source: org_study_id
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