Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications
Conditions
Interventions
Intervention1: Diperoxochloric Acid (DPOCL) topical solution: This pack contains two bottles (Bottle A and Bottle B). In bottle A, each ml of solution contains Diperoxochloric Acid Concentrate (1.16 m
Sponsors
Centaur Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with either Type I or II - diabetes mellitus 2. Subjects having random blood sugar [RBG] of 3. Subjects having glycosylated hemoglobin of less than 12% 4. Age: >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 7. Subjects with Ankle-Brachial Pressure Index [ABPI] > 0.7 8. All the subjects willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form
Exclusion criteria
Exclusion criteria: 1. Subjects with more than 3 ulcers 2. Subjects 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. Subjects having history of active Charcotâ??s foot of the study foot within 6 months of screening 7. Treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy 8. Revascularization surgery performed 9. Pregnant or nursing mothers 10. Mentally or neurologically disabled subjects that are considered not fit to approve their participation in the study 11. Subjects with Ankle-Brachial Pressure Index [ABPI]
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. No. of days taken for complete wound closure from onset of wound Timepoint: 1. Percentage of patients achieving Complete Wound Closure (CWC) 2. Percentage reduction in the wound surface area at each visit 3. No. of days taken for complete wound closure from onset of wound All the outcome will be assessed on day 0, day 7, day 14, day 21, day 28, day 42, day 56, day 70. | — |
Secondary
| Measure | Time frame |
|---|---|
| 4. Clinical examination of ulcer â?? Wound Evaluation Score, which consists of six parameters (erythema, edema, purulence, necrotic tissue, fibrin and pain) 5. Quality of life will be assessed by Karnofsky Performance Status (KPS) ScaleTimepoint: Day 0, Day 7, Day 14, Day 21, Day 28, day 42, day 56, day 70 | — |
Countries
India
Contacts
Public ContactDr G Arun Maiya
Kasturba Medical College, MAHE, Manipal
Outcome results
None listed