Clinical trial NCT02236793: A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Foot Ulcer
Lead sponsor: Adocia
Sponsor class: INDUSTRY
Collaborators: name: Virchow Group
First posted: 2014-09-11
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of complete wound closure.
timeFrame: 20 weeks
Secondary outcomes:
measure: Time to achieve complete wound closure.
timeFrame: 20 weeks
measure: Percentage reduction in total ulcer surface area at each visit.
timeFrame: 20 weeks
measure: Incidence of complete wound healing
timeFrame: 10 weeks
measure: Number of ulcer recurrence observed 12 weeks after wound healing.
timeFrame: 32 weeks
measure: Treatment emergent adverse events.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Mediciti Hospital
state: Andhra Pradesh
city: Mumbai
country: India
facility: SL Raheja Hospital
state: Maharashtra
city: Chennai
country: India
facility: M.V. Hospital for Diabetes (P) Ltd
state: Tamilnadu
city: Chennai
country: India
facility: Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre
state: Taminadu
city: Ahmedabad
country: India
facility: B.J. Medical College and Civil Hospital
city: Ahmedabad
country: India
facility: Dr Jivraj Mehta Smarak Health Foundation
city: Ahmedabad
country: India
facility: Sangini Hospital
city: Ahmedabad
country: India
facility: V.S. General Hospital & Sml NHL Municipal Medical College Sheth
city: Aligarh
country: India
facility: Rajiv Gandhi Centre for Diabetes and Endocrinology
city: Chandigarh
country: India
facility: Govt Medical College and Hospital
city: Chennai
country: India
facility: Sri Ramachandra Medial Centre
city: Chennai
country: India
facility: The Madras Diabetes Research Foundation
city: Chennai
country: India
facility: The Madras Medical Mission
city: Hyderabad
country: India
facility: Gandhi Medical College & Hospital
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
city: Hyderabad
country: India
facility: Sumana Hospital
city: Hyderabad
country: India
facility: Surakshaka diabetic Centre(P) Ltd
city: Jaipur
country: India
facility: SMS Medical College & Attached Hospital
city: Kolkata
country: India
facility: ILS Hospital
city: Kolkata
country: India
facility: IPGME & R and SSKM Hospital
city: Kolkata
country: India
facility: Nightingale Hospital
city: Kolkata
country: India
facility: Rabindranath Tagore International Insitute of cardiac Sciences
city: Mohali
country: India
facility: Fortis Hospital Phase
city: Mumbai
country: India
facility: Seth G.S. Medical College and K.E.M Hospital
city: Mysore
country: India
facility: Mysore Medical College & Research Institute
city: Nagpur
country: India
facility: Govt Medical college & Hospital Medical Square
city: Nagpur
country: India
facility: Indira Gandhi Govt Medical College and Hospital
city: Pune
country: India
facility: B.J. Govt. Medical College and Sassoon Hospital
city: Pune
country: India
facility: Inamdar Multispeciality Hospital
city: Pune
country: India
facility: Poona Hospital & Research Centre
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Vishakapatnam
country: India
facility: King Georges Hospital
Study officials:
affiliation: SL Raheja Hospital
name: Arun Bal, MD
role: PRINCIPAL_INVESTIGATOR
References: