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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236793
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
Virchow Group
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: BioChaperone PDGF-BB Other: Standard of Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Becaplermin

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
Drug: BioChaperone PDGF-BB
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
Other: Standard of Care



Primary Outcome Measures :
  1. Incidence of complete wound closure. [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Time to achieve complete wound closure. [ Time Frame: 20 weeks ]
  2. Percentage reduction in total ulcer surface area at each visit. [ Time Frame: 20 weeks ]
  3. Incidence of complete wound healing [ Time Frame: 10 weeks ]
  4. Number of ulcer recurrence observed 12 weeks after wound healing. [ Time Frame: 32 weeks ]
  5. Treatment emergent adverse events. [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236793


Locations
Show Show 32 study locations
Sponsors and Collaborators
Adocia
Virchow Group
Investigators
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Principal Investigator: Arun Bal, MD SL Raheja Hospital
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02236793    
Other Study ID Numbers: BC1-CT4
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Becaplermin
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Anticoagulants
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs