Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Herbal topical spray: Herbal topical spray is a unique alkaline formulation. It is a combination of extracts of
herbs and natural amino sugars and natural adjuvants.
The unique Herbal T
Sponsors
Inzpera Healthsciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/female of >=18 and 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.
Exclusion criteria
Exclusion criteria: 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with complete healing of ulcer. Complete healingâ?? will be defined as absence of visible wound by complete epithelialization.[Time Frame: 10 weeks ]Timepoint: 10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time taken for achieving complete wound closure from the baseline [Time Frame: 10 weeks ] 2. Change in wound surface area from baseline [ Time Frame: 10 weeks ] Mean percent change in wound area from baseline at each visitTimepoint: 10 weeks | — |
Countries
India
Contacts
Public ContactDivya C
Bioagile Therapeutics Pvt. Ltd
Outcome results
None listed