Health Condition 1: E104- Type 1 diabetes mellitus with neurological complications Health Condition 2: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: WOXheal (Diperoxochloric Acid Topical Solution): This pack contains two bottles:
Bottle A: Diperoxochloric acid concentrate (each ml of solution contains: Dipero
Sponsors
Centaur Pharmaceuticals Pvt Ltd
CENTAUR PHARMACEUTICALS PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with either Type I or II diabetes mellitus. 2)Patients having random blood sugar [RBG] of Less than 250 mg/dL on standard anti-diabetic treatment 3)Patients having glycosylated hemoglobin of less than 12%. 4)Age: more than 18 years of either gender (Male/ Female). 5)Ulcers with wound surface area measured by greatest length, greatest width between 1 cm2 and 25 cm2 post debridement on the day 0. 6) 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 graded as stage I A, II A or I B on University of Texas wound classification system 7) Patients with Ankle-Brachial Pressure Index [ABPI] more than 0.7 8) All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1) Patients with more than 3 ulcers. 2) Patients with ulcers measuring wound surface area more than 25 cm2. 3) Ulcers caused by venous or arterial insufficiency or electrical or chemical burns. 4) Ulcers caused by surgery and especially amputation surgery. 5) Ulcers showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement. 6) Patients having history of active Charcoat’s foot of the study foot within 6 months of screening. 7) Patients having severe or poorly controlled diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL). 8) Patients having glycosylated hemoglobin of more than 12%. 9) Patients having progressive weight loss. 10) Treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy. 11) Other diseases, which can alter the course of diabetic foot ulcer such as connective tissue disease, renal failure (serum creatinine more than 3mg /dL) liver failure, malignancy. 12) Revascularization surgery performed less than 8 weeks before entry in the study. 13) Pregnant or nursing mothers. 14) Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study. 15) Patients with Ankle-Brachial Pressure Index [ABPI] less than 0.7
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of patients achieving Complete Wound Closure (CWC). 2.Percentage reduction in the wound surface area at each visit. 3.Patients with more than or equal to 25% reduction in wound surface area will be continued in the treatment and will be defined under treatment responders. 4. An improvement in percentage change in wound surface area after 4 weeks (Day 28) of treatment is a strong predictor of complete healing. 5.No. of days taken for complete wound closure from onset of wound. Timepoint: at every visit that is week 1 week 2 week 3 week 4 week 6 week 8 and week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical examination of ulcer – Wound Evaluation Score, which will consists of six parameters (erythema, edema, purulence, necrotic tissue, fibrin and pain) scored on 4 point visual analogue scale from 0 to 3 where 0 is no symptom, 1 is mild,2 is moderate and 3 is severe intensity symptom. 2. Quality of life will be assessed by Karnofsky Performance Status (KPS) ScaleTimepoint: at every visit that is week 1 week 2 week 3 week 4 week 6 week 8 and week 10 | — |
Countries
India
Contacts
Public ContactMs Aakansha Singh
Centaur Pharmaceuticals Pvt Ltd
Outcome results
None listed