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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: BioChaperone PDGF-BB
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioChaperone PDGF-BB<br>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<br> <br> |
| Placebo Comparator: Standard of Care<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete wound closure. |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |