Study to Evaluate the Efficacy and Safety of Wound Healing Topical Spray in Patients withDiabetic Foot Ulcer.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/04/041672
- Lead Sponsor
- Inzpera Healthsciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male/female of >=18 and <=75 years of age.
2.Patient who can and willing to provide written Informed Consent.
3. Patient with a history of type 2 diabetes mellitus 4.
4.Patient having Random Blood Sugar [RBG] Ë? 250 mg/dL, on standard antidiabetic treatment.
5. Patient having glycosylated hemoglobin (HbA1c) of less than 12% (based on the existing reports).
6.Patient with at least ONE but not more than THREE DFU with wound surface area measured between 1 cm2 and 12 cm2 and depth post-debridement between 1cm2 -2cm2 , on the day of randomization (wound surface area measured by greatest length, greatest width).
7.Patient with ulcer located at or below malleolar region of foot and Superficial ulcer, Ulcer without infection, mild and moderate infection. Stage I-A, II-A or I-B on University of Texas wound classification system.
1.Patient Ë? 18 or Ë? 75 years of age.
2. Pregnant and/or nursing woman.
3. Patient with more than 3 ulcers.
4. Patient with ulcers measuring wound surface area more than 12 cm2 and depth more than 2cm2.
5. Patient having severe or poorly controlled Type II diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).
6. Patient having HbA1c of more than 12%.
7. Patient with severe ischemia with Ankle-Brachial Index (ABI) <= 0.7.
8. Patient having progressive weight loss.
9. Patient having poor nutritional status (S. albumin less than 2.5g /dL).
10. Patient with ulcer deep into bone and joint or Osteomyelitis or Severe ulcer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects with complete healing of ulcer. <br/ ><br>Complete healingâ?? will be defined as absence of visible wound by complete epithelialization.[Time Frame: 10 weeks ]Timepoint: 10 weeks
- Secondary Outcome Measures
Name Time Method 1. Time taken for achieving complete wound closure from the baseline [Time Frame: 10 weeks ] <br/ ><br>2. Change in wound surface area from baseline [ Time Frame: 10 weeks ] <br/ ><br>Mean percent change in wound area from baseline at each visitTimepoint: 10 weeks