3D printed footwear for trophic ulcers

The Impact of Custom 3D Printed Footwear on Diabetic Foot Ulcer Healing: A Randomized Controlled Trial - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083440

Enrollment

Registered

2025-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: E106- Type 1 diabetes mellitus with other specified complications

Interventions

Intervention1: 3D PRINTED FOOTWEAR: The project aims to explore the effectiveness of custom-made 3D printed footwear in promoting the healing of diabetic foot ulcers. This study will compare the heali

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults 18+ with a diagnosis of diabetes mellitus. 2. Presence of plantar trophic foot ulcers. 3. Ulcer grade 1 or 2 on the Wagner Ulcer classification system. 4. No signs of active infection at the ulcer site. 5. Ability to comply with study procedures and follow-up visits

Exclusion criteria

Exclusion criteria: 1. Major foot deformities (eg: Charcot foot) 2. Severe peripheral arterial disease. 3. Cognitive impairment preventing informed consent.

Design outcomes

Primary

Measure	Time frame
Improved Ulcer Healing Rates Better Pressure Redistribution Enhanced Patient Comfort and Satisfaction Reduced Ulcer Recurrence Cost-Effectivenes Timepoint: At Baseline	—

Secondary

Measure	Time frame
Enhanced Patient Comfort & Satisfaction Reduced Ulcer Recurrence Cost-Effectivenes Timepoint: 6 weeks	—

Countries

India

Contacts

Public ContactOzair Hassan

SAVEETHA MEDICAL COLLEGE

gmkumaran99@gmail.com9840170308

Outcome results

None listed

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