Clinical Trial of wound healing solution in diabetic foot ulcer

Phase 3

Completed

• Conditions: Health Condition 1: null- Diabetic Foot UlcerHealth Condition 2: E114- Type 2 diabetes mellitus with neurological complications

• Registration Number: CTRI/2012/02/002415
• Lead Sponsor: Centaur Pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-09-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 311

Inclusion Criteria

All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form, understand the sense of the Clinical Trial and able to come for follow-ups.

Patients diagnosed with either Type I or II - diabetes mellitus.

Patients having random blood sugar [RBG] of 250 mg/dL on standard antidiabetic treatment

Patients having glycosylated hemoglobin of less than 12%.

Age: 18 years but 75 years. [75 completed years]

At least 1 but not more than 3 full thickness [i.e. extending into subcutaneous tissue or beyond] ulcer at foot or below malleolus with at least 4 weeks history and ulcer that does not involve bone, tendons, ligaments or muscles and graded as stage I-A, II-A or I-B on University of Texas wound classification system

Ulcers with wound surface area measured by greatest length, greatest width between 1 cm2 and 16 cm2 post-debridement on the day of randomization.

Patients with Ankle-Brachial Pressure Index [ABPI] > 0.7

Exclusion Criteria

Patients with more than 3 ulcers

Patients with ulcers measuring wound surface area more than 16 cm2

Ulcers caused by venous or arterial insufficiency or electrical or chemical burns

Ulcers caused by surgery and especially amputation surgery

Ulcers showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement, osteomyelitis.

Patients having history of active Charcoat?s foot of the study foot within 6 months of screening

Patients having severe or poorly controlled diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).

Patients having glycosylated hemoglobin of more than 12%.

Patients having progressive weight loss.

Patients having poor nutritional status (S. albumin less than 2.5g /dL).

Treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy.

Other diseases, which can alter the course of diabetic foot ulcer such as connective tissue disease, renal failure (serum creatinine 3mg /dL) liver failure, malignancy.

Revascularization surgery performed 8 weeks before entry in the study.

Pregnant or nursing mothers.

Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.

Patients with Ankle-Brachial Pressure Index [ABPI] less than 0.7

Study & Design

• Study Type: Interventional
• Study Design: Not specified