Brief Summary of the Study

Chronic wounds, such as diabetic foot ulcers, venous ulcers, and pressure ulcers, present significant healthcare challenges due to their resistance to standard treatments and associated complications like infections, necrosis, and amputations. Current management strategies often focus on symptom control rather than addressing underlying biological deficiencies.

Amnion, derived from the innermost layer of the placenta, has gained attention as a potential therapeutic agent for enhancing wound healing. Rich in growth factors, extracellular matrix components, and cytokines, amnion exhibits anti-inflammatory, pro-regenerative, and immunomodulatory properties. Its use has shown promising results in preliminary studies, but there remains a need for robust evidence to establish its efficacy and safety in chronic wound management.

This single-center prospective interventional study aims to evaluate the healing effects of processed human amnion applied as a dressing in patients with chronic non-healing wounds. Conducted at MS Ramaiah Hospitals, Bengaluru, the study will recruit 64 participants who meet specific inclusion criteria, such as chronic wounds persisting for at least four weeks despite standard care. Participants will receive amnion dressings, and outcomes will be assessed over a specified follow-up period.

Primary outcomes include wound closure rates, while secondary outcomes focus on pain reduction, improvements in quality of life, and cost-effectiveness. Data will be analyzed using paired t-tests to assess the efficacy of amnion therapy.

The study’s findings aim to provide valuable insights into the role of amnion in wound healing, contributing to the advancement of wound care practices and scientific understanding of tissue regeneration. This research could potentially establish amnion-based therapies as a standard of care for managing chronic wounds, improving patient outcomes and reducing healthcare burdens.