Study on the safety and efficacy of BIOCHAPERONE 1 in the treatment of diabetic foot ulcers.

Phase 1/2

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2011/091/000202
• Lead Sponsor: Virchow Biotech Pvt Ltd

Brief Summary

Diabetic foot ulcer is a common complication of diabetes that occurs in an estimated 15% of diabetic patients. Infection and gangrene, the two major complications of ulcers, lead to amputation in 4 to 7 per 1.000 patients with diabetes. With an over 5% worldwide prevalence of diabetes, the morbidity and mortality and the expenses associated with diabetic foot ulcers are substantial both for the patients and for the health care systems. The standard wound care of diabetic foot ulcer relies primarily on pressure relief, debridement and maintenance of a moist wound environment. In addition, growth factor therapy with platelet-derived growth factor (PDGF-BB) has demonstrated significant clinical benefit by increasing the incidence of complete wound closure and by accelerating wound healing. RhPDGF-BB formulated as a gel (Regranex® Gel 0.01%, Systagenix Wound Management, formerly Johnson & Johnson; and Healace®, Virchow Biotech Pvt, Ltd) is the only growth factor approved for the treatment of neuropathic diabetic foot ulcers. However, the limited efficacy of Regranex® Gel (healing rate only increased by 15% versus placebo, still leaving 50% of the patients unhealed), the inconvenience of the treatment regimen (daily application of the gel and once or twice daily wound care), and the high cost of the associated nursing care are strong impediments to its use in routine ulcer care management. Adocia has developed BioChaperone PDFG-BB, a new liquid formulation designed for an application of rhPDGF-BB as a spray, and only every two days, hence reducing the burden and nursing cost associated with the gel dose regimen. The aim of this study is to establish the proof of concept in a Phase I/II clinical trial with two objectives: i) establish equivalence to Regranex® Gel with two major advantages (improved compliance and reduced nursing care and thus costs), and ii) assess the efficacy of a double dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Study Completion: 2011-05-09
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• 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.
• Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
• Well controlled infection or cellulitis (systemic antibiotherapy).
• Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
• 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.
• Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening.
• Non-nursing.
• Signed informed consent before any study procedure.

Exclusion Criteria

• 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.
• Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
• Use of investigational drug/device within 30 days.
• Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of complete wound healing	20weeks

Secondary Outcome Measures

Name	Time	Method
Time to achieve complete wound closure	10 weeks
percentage reduction in total ulcer surface area at each visit	once in a week

Trial Locations

Locations (9)

Amrutha Diabetic Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Diabetes Clinics & Research centre; 🇮🇳 Nagpur, MAHARASHTRA, India

Dr. Mohan's Diabetes Speciality Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

MN Area Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Prasad Multi Speciality Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Raheja Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

S.K. Diabetes Research and Education Centre; 🇮🇳 Kolkata, WEST BENGAL, India

Shravana Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Vijay Vachharajani Memorial; 🇮🇳 Rajkot, GUJARAT, India

Amrutha Diabetic Centre

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr. Karthika Laksmi

Principal investigator

karthika@kanukolamu.com