Punga thylam for madhumega viranam (Diabetic ulcer)

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus with other specified complications,

• Registration Number: CTRI/2023/06/054116
• Lead Sponsor: National Institute of Siddha

Brief Summary

It is an open non randomized, single arm, single centric, trail to determine the therapeutic effectiveness of punga thailam in the management of madhumega viranam (diabetic foot ulcer). Patients with diabetic foot ulcers will be enrolled for the study as per inclusion and exclusion criteria. After the enrollment, treatment will be given with punga thailam. Regular wound dressing will be done, and the ulcer will be assessed weekly with the use of leg ulcer measurement tool.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Study Completion: 2024-05-31
• Last Update Posted: 2024-09-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age: >18 years Sex: Male, Female and Transgender Superficial ulcer, Destruction of the thickness of the skin/ Penetrates through skin not affecting bone (Wagner’s Classification I & II) Willing to give specimen of blood for the investigation.
• Willing to take photograph.
• Willing to participate in trial by signing the informed consent.
• Good control of Diabetes Mellitus.

Exclusion Criteria

Ischemic foot Deep Ulcer (cellulitis) / Osteomyelitis with Ulceration or abscess/ Gangrenous patches limited to toes or part of the foot/ Gangrene of the entire foot (Wagner’s classification II, III, IV & V) Varicose ulcer Hansen’s disease Tuberculous ulcer Any active neoplastic disease Necrotizing fasciitis The patient who has uncontrolled diabetes will be treated for diabetes mellitus and after that he/she will be included for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome will be measured with the use of leg ulcer measurement tool.	12 months

Trial Locations

Locations (1)

Ayothidoss Pandidhar Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Ayothidoss Pandidhar Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr J Lavanya

Principal investigator

7092061802

jclkasilingam1022@gmail.com