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Healing of chronic diabetic foot ulcers.

Efficacy of collagen granules and collagen foam in the healing of chronic diabetic foot ulcers: A Randomized, Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/039944
Enrollment
140
Registered
2022-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: L975- Non-pressure chronic ulcer of other part of foot

Interventions

Intervention1: Collagen granules and collagen foam: Collagen granules and collagen foam application over diabetic foot ulcers compared with normal saline application. Duration 12 weeks Control Interve

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients >18 years with chronic diabetic foot ulcers and of more than one-month duration. 2. Patients with controlled blood sugars. 3. Ulcers less than 20 cm2 size

Exclusion criteria

Exclusion criteria: 1. Ulcers with suspected/proven malignancy. 2. Patients with peripheral vascular disease. 3. Patients with hypersensitivity to collagen, mupirocin, and metronidazole 4. Psychiatric diseases /un-cooperative patients. 5. Clinically moribund patients. 6. Anticipated transfer to acute care/ operative intervention like amputations, extensive debridements, drainage procedures within 12 weeks. 7. Spreading ulcers 8. Infected/ unhealthy ulcers 9. Ulcers with bone exposed

Design outcomes

Primary

MeasureTime frame
Rate of ulcer healing within 12 weeks of randomization.Timepoint: 12 months—

Secondary

MeasureTime frame
Duration of ulcer healing. Timepoint: at baseline, 4 weeks and 8 week; Time to wound sterility. Timepoint: at baseline, 4 weeks and 8 week;Cost of therapy Timepoint: at baseline, 4 weeks and 8 week;Number of minor amputations prevented Timepoint: at baseline, 4 weeks and 8 week;Rate of healing compared to the age of ulcer.Timepoint: at baseline, 4 weeks and 8 week;The number of debridements required after inclusion in the study.Timepoint: at baseline, 4 weeks and 8 week—

Countries

India

Contacts

Public ContactDr Ritesh Panda

All India Institute of Medical Sciences

tem_ritesh@aiimsbhubaneswar.edu.in9999326904

Outcome results

None listed

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