A Clinical Study to Evaluate the Efficacy of a Combination of Internal Medicines and Local Treatment in Chronic Non-Healing Wounds

Phase 2

Conditions: Health Condition 1: L984- Non-pressure chronic ulcer of skin, not elsewhere classified

Registration Number: CTRI/2024/04/066064

Lead Sponsor: All India Institute of Ayurveda, New Delhi.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1)Patients of the age group 19-70 years having Chronic Non-Healing wound (Wound which is not healed by 40-50% after 4 weeks of standard treatment) of any of the following types-

-Venous Ulcers

-Diabetic Ulcers

-Trophic Ulcers

-Burns

ICD Code-

ICD-10 code 2024 ICD-10-CM Diagnosis Code L98.499

Non-pressure chronic ulcer of skin of other sites with unspecified severity

will be followed.

Following synonyms from ICD will be excluded-

1.Chronic ulcer of Left ear

2.Chronic Ulcer of Right ear

3.Diabetes Type 1 with Chronic Skin Ulcer

4.Diabetes Type 1 with Diabetic skin Ulcer

Exclusion Criteria

1)Patients with WBC count above 12000/mm3

2)Immunocompromised patients like HIV, HbsAg, HCV positive patients

3)Pressure sores

4)Known cases of TB, Leprosy ulcer, Malignant Ulcers

5)Pregnant females

6)Uncontrolled Diabetes, Hypertension.

7)Hepatic and Renal Failure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
More than 50 % healing of the chronic non healing wound.Timepoint: 28th day

Secondary Outcome Measures

Name	Time	Method
Digital Image of WoundTimepoint: Day 0, Day 14, Day 28;Growth Factor – VEGF-A using ELISA MethodTimepoint: Day 0, Day 14, Day 28;Histopathological Analysis of by Edge BiopsyTimepoint: Day 0, Day 14, Day 28;Hydroxyproline assay- ELISA methodTimepoint: Day 0, Day 14, Day 28;Wound Swab CultureTimepoint: Day 0, Day 14, Day 28