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The application of amniotic membrane as a biological dressing for the treatment of non- healing foot wound in patients with type 2 diabetes mellitus in comparison with application of conventional saline dressings.

To compare the efficacy of amniotic membrane as the biological dressing versus conventional saline dressing in management of lower limb diabetes related foot ulcer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084066
Enrollment
34
Registered
2025-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Amniotic Membrane: Application of amniotic membrane obtained from the placenta as a dressing for diabetic foot ulcers. Control Intervention1: Conventional saline dressings: Application

Sponsors

PRAVEEN RICHARD T
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients with Type 2 DM with a diabetic foot ulcer 2 Age greater than 18 years 3 Patients are willing to follow up for 4 weeks 4 Diabetic foot ulcer involving epidermis, dermis, and subcutaneous tissue, muscle only but not bone.

Exclusion criteria

Exclusion criteria: 1)Presence of underlying osteomyelitis. 2) Presence of necrotizing soft tissue infection. 3) Hypoalbuminemia (albumin less than 2gm%). 4) Anemia (Hb less than 8 gm%). 5) Patient should not be any antibiotics for a systemic illness. 6) Patients with chronic kidney disease or known decompensated liver disease non-diabetes-related foot ulcers. 7) Ulcers with sinus.

Design outcomes

Primary

MeasureTime frame
Reduction in the size (area) of the diabetic foot ulcersTimepoint: 4 weeks—

Secondary

MeasureTime frame
To compare the change in PUSH score. To compare the pain scale VAS score. Type of granulation tissue.Timepoint: 4weeks—

Countries

India

Contacts

Public ContactBobeena Rachel Chandy

CHRISTIAN MEDICAL COLLEGE VELLORECHRISTIAN MEDICAL COLLEGE VELLORE

bobeenachandy@cmcvellore.ac.in04162285274

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026