Study of Preserved Amniotic Membrane with Antibiotics as a Dressing for Diabetic Ulcers

Antibiotic Impregnated Cryopreserved Amniotic Membrane use in Diabetic ulcer dressing - nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102013

Enrollment

Registered

2026-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Antibiotic impregnated cryopreserved amniotic membrane: Antibiotic impregnated cryopreserved amniotic membrane in diabetic ulcer dressing Control Intervention1: saline , povidone iodine

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged above 18 yrs 2. patients diagnosed with Diabetes Mellitus 3. Patients with sugars under control 4. patients with Wagner grade I II and III diabetic ulcers 5. patients willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients with Wagner grade IV or V ulcers 2.Patients with Critical limb ischemia 3.Patients with Active osteomyelitis 4.Patients with Known allergy to antibiotics used 5.Immunocompromised patients 6.Pregnancy or lactation 7. Patients not willing to give consent

Design outcomes

Primary

Measure	Time frame
Percentage of reduction in ulcer area Time for wound healingTimepoint: baseline , 1 week , 4 weeks	—

Secondary

Measure	Time frame
Rate of infection control Need for surgical intervention Adverse reaction to dressingTimepoint: Baseline weekly for 4 weeks at completion of treatment	—

Countries

India

Contacts

Public ContactDr Parimala A

Saveetha Medical College and Hospital

parimalachats2002@yahoo.com8939658288

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026