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A Study on using Amnion (a layer of human placenta) for healing chronic wounds

THE EFFECT OF AMNION ON WOUND HEALING IN CHRONIC WOUNDS - A SINGLE CENTRE INTERVENTIONAL STUDY

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078663
Enrollment
64
Registered
2024-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: I830- Varicose veins of lower extremities with ulcer

Interventions

Intervention1: Amnion sheet application: Amnion is obtained from the placenta of voluntary donors, after careful screening. The amnion sheets are then treated with antibiotics and preserved. These pro

Sponsors

DR MOHIT NAREN KONDAPALLI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with chronic wounds, such as diabetic foot ulcers, venous ulcers, pressure ulcers, or other non-healing wounds persisting for at least four weeks despite standard wound care. Wounds located on anatomical sites amenable to the application of amnion Patients with chronic wounds without clinical signs of infection or systemic infection at the time of enrolment Patients with a history of standard wound care treatments, including debridement, offloading, and appropriate wound dressings, but no recent use of advanced wound therapies such as growth factors or cellular therapies Patients with stable medical conditions and no acute systemic illnesses that may interfere with wound healing or study participation

Exclusion criteria

Exclusion criteria: Patients with Acute Wounds / Acute Infections Patients with Terminal illnesses / Non-compliant patients Patients with a history of Prior Radiation Therapy Pregnant Patients / Immunocompromised patients Patients with arterial insufficiency as confirmed by ABI & TCPO2 Patients with Uncontrolled Diabetes

Design outcomes

Primary

MeasureTime frame
Wound closure rates Timepoint: 6-8 weeks

Secondary

MeasureTime frame
Pain reduction Improvements to quality of life Cost-effectiveness analysisTimepoint: 8-12 weeks

Countries

India

Contacts

Public ContactMohit Naren Kondapalli

MS RAMAIAH MEDICAL COLLEGE & HOSPITAL

sanjaycdesai.rmc@msruas.ac.in9845290575

Outcome results

None listed

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