A phase I/II/, multicentre, randomized, controlled and open label trial comparing the efficacy and safety of three dose regimens of BioChaperone PDGF-BB to becaplermin gel for the treatment of diabetic foot ulcer. - BC1-CT1

Virchow Biotech Pvt Ltd0 个研究点目标入组 192 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
•2.Single full-thickness plantar ulcer of the extremity (below the malleolus) 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).
•?Chronic ulcer of at least six weeks despite appropriate wound care.
•3. Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cmÂ², both inclusive.
•4. Well controlled infection or cellulitis (systemic antibiotherapy).
•5. Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
•6. Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index > 0.60, or ankle systolic pressure > 70 mmHg or toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
•7. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing.
•8. Signed informed consent before any study procedure.

•1. Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
•2. Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
•?Active osteomyelitis affecting the area of the target ulcer.
•?Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL).
•3. Known connective tissue or malignant disease.
•4. Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
•8. Use of investigational drug/device within 30 days.
•9. Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days.
•6. Vascular reconstruction within 8 weeks.
•7. 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.

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