Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Standard Ulcer Care plus BotroClot: Route: Topical
Dosage: Apply 2 drops per sq.cm of wound area (10drops/sq.inch)
Frequency/day: Once a day
Duration: 8 Weeks
Control Intervention1: St
Sponsors
Jagdale industries pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Mentally Sound 2. Consents to be a part of the study 3. Men and women 30 to 75 years or older. 4. Capacity of attending the visits at the research site on alternative days. 5. Confirmed diagnosis of DM type 1 or 2 according to the guidelines from the American Diabetes Association (ADA). 6. Presence of 1 DFU, less than 15cm in its biggest diameter, belonging to Grade 2 or less according to Wagners Classification of DFUs extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles. 7. Adequate arterial blood supply to be measured through Ankle Brachial Pressure Index (ABPI). ABPI should be lower than 1.3 (which is frequently related to medial artery calcification) 8. Pharmacological treatment for glycemic control 9. HbA1c more than 7.5
Exclusion criteria
Exclusion criteria: 10. Distal necrosis of the limb with the ulcer. 11. Patients with severe DVT/Varicose veins/ Varicose ulcers. 12. Known history of allergy or contraindications for BotroClot, its components 13. Patients with mental illness. 14. Individuals on any other medications or nutritional supplements that may influence BotroClot i.e. any other coagulant or haemostatic medication such as tranexamic acid or ethamsylate. 15. Individuals not willing to follow protocol specified guidelines. 16. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening for this study or during the course of the study. 17. History of renal failure or dialysis, hypercalcemia, severe liver disease (cirrhosis), sarcoidosis, or other granulomatous diseases (Wegener) 18. Previously diagnosed cases of immune-compromised status like HIV, Hepatitis B/C, Tuberculosis, Cancer, etc. or deranged liver or kidney tests 19. Subjects taking or need to take systemic/oral steroid treatment and or any kind of immunosuppressive therapy in the pre-study and during the study period 20. Subjects participating in any other clinical study or having participated in any other study 21. Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Ulcer area reduction (wound area) [ Week 1, Week 2, Week 4, Week 6, Week 8] 2.Reduction in wound evaluation score (D0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 and Week 8) Timepoint: Day0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 and Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events between the groupsTimepoint: Day 1 to 56 | — |
Countries
India
Contacts
Public ContactMr Raghavendra K V
Radiant research services pvt. Ltd
Outcome results
None listed