ocal Application of Yashad-Jatyadi Ointment in the management of Diabetic Foot Ulcer

Phase 2

• Conditions: Health Condition 1: G64- Other disorders of peripheral nervous system

• Registration Number: CTRI/2020/07/026422
• Lead Sponsor: DrRamesh B Jadhav

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Patients of either sex in the age group of 21 to 70 years (both inclusive).

2)Patients having either Type I or Type II diabetes with non-healing diabetic foot ulcers.

3)Diabetic patients having HbA1C <8.

4)Patients having either Diabetic foot ulcers with the following ulcer characteristics :

a)Neuropathic and mild Neuro-ischaemic diabetic foot ulcer (single or multiple ulcers)

b)Diabetic foot ulcers with Grade 1 to 2 (Wagenerâ??s classification)

c)Duration of ulcer more than 1 month

d)Surface area of the Non-Healing Ulcer more than 1 cm2.

Exclusion Criteria

1)Patients with ischemic Ulcers (Diagnosed Clinically and /OR with Doppler)

2)Known cases of Severe/Chronic Hepatic or Renal disease

3)Known cases of any active malignancy.

4)Patients giving history of significant cardiovascular event < 12 weeks prior to randomization.

5)Chronic alcoholics / Alcohol abuse

6)Patients ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.

7)Patients X-ray chest showing any active lesion of tuberculosis.

8)Patients having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.

9)Patients using any other investigational drug within 1 month prior to recruitment.

10)Known hypersensitivity to any of the ingredients used in study drug.

11)Pregnant and lactating females.

12)Patients currently participating in any other clinical study or any education treatment program for Ulcers.

13)Patients having any other medical or surgical condition considered unsuitable for his/her participation in the study as per investigatorâ??s judgment.

14)Patients receiving drugs, which may interact with the study therapeutic protocol such as glucocorticoids, immunosuppressive and cytotoxic drugs.

15)Patients who have undergone ulcer treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Change in Ulcerated area(weekly till either complete ulcer healing or 3 months whichever is earlier)Timepoint: Day-5,Day0,Day7,Day14,Day21,Day28,Day35,Day42,Day49,Day56,Day63,Day70,Day77,Day84,Day91

Secondary Outcome Measures

Name	Time	Method
1)Assessment of changes in ulcer <br/ ><br>2)Assessment of changes in ulcer by DigitalPhotographs <br/ ><br>3)Assessment of time required for complete healing <br/ ><br>4)Assessment of requirement of Antibiotics,Anti-inflammatory drugs <br/ ><br>5)Assessment of adverse event by clinical evalution,AE/SAE recording,vitals and Lab Parameters. <br/ ><br>6)Assessment of clinical global evalution for overall efficacy by physician and by the patient. <br/ ><br>7)Assessment of overall acceptability/tolerability by subject and physician.Timepoint: Day-5,Day0,Day7,Day14,Day21,Day28,Day35,Day42,Day49,Day56,Day63,Day70,Day77,Day84,Day91