Clinical trial on Healing of diabetic foot ulcers.
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2023/03/050888
- Lead Sponsor
- Jagdale industries pvt. Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <1 month prior to screening in the present 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method