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imbapatradi vrana varti in the management of Diabetic ulcer

Phase 2
Conditions
Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: L979- Non-pressure chronic ulcer of unspecified part of lower legHealth Condition 3: E10- Type 1 diabetes mellitusHealth Condition 4: E11- Type 2 diabetes mellitus
Registration Number
CTRI/2022/08/044668
Lead Sponsor
Dr Rengapadmini B
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Diabetic ulcer less than one month with controlled Diabetes mellitus (HbA1c < or equal 180mg/dl, FBS < or equal 180 mg/dl, PPBS < or equal 250 mg/dl, RBS < or equal 200 mg/dl).

2.Patients on medications (Oral Antihyperglycemic agents/ Insulin) for Diabetes mellitus.

3.Diabetic ulcer of Grade 1(Superficial ulcers involving full skin thickness) and Grade 2(Deep ulcers penetrating down to ligaments and muscle but no bone involvement) as per Wagner Classification of Diabetic Foot Ulcer.

4.Diabetic ulcer due to Ischemic and Infective pathology.

Exclusion Criteria

1.Uncontrolled Diabetes mellitus and Hypertension.

2.Diabetic ulcer of Grade 3 and above as per Wagner Classification of Diabetic foot ulcer.

3. Diabetic ulcer due to Neuropathic pathology, Osteomyelitis and Tuberculosis.

4. Patients suffering from Malignancies.

5. Patients with systemic disorders of liver and renal origin.

6. Patients with nutritional deficiency disorders.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Improvement in the total score evaluated through Bates Jensen Wound Assessment Scale. <br/ ><br> <br/ ><br>2. Achieving Wound Regeneration and reduction of pain. <br/ ><br>Timepoint: 6 Weeks
Secondary Outcome Measures
NameTimeMethod
Any general improvement in mental, physical and social health among the participants.Timepoint: 3 months
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