Health Condition 1: null- Diabetic Foot Ulcer Health Condition 2: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Diperoxochloric acid: 3.5 ml for 5 X 5 cm inner dressing to be changed every third day. Outer dressing, which is dry gauge will be changed every day.
Control Intervention1: Isotonic 0.9
Sponsors
Centaur Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving complete wound closureTimepoint: Any point of time | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time taken for achieving complete wound closure from the onset of wound 2. Percentage reduction in the wound surface area at each visit 3. Clinical status of the treated wounds after 10 weeks 4. Treatment responders defined as at least 50% reduction in wound surface area at week 4 and week 10 Timepoint: Week 4 and week 10 | — |
Countries
India
Contacts
Public ContactDr Mukund Zarapkar
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt. Ltd.
Outcome results
None listed