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The wound microbiome alteration in chronic lower extremity ulcers with and without SCFA treatment

Impact of EpiFAst Vs. normal Saline dressing on the healing of chronic lower extremity ulcers: A pilot, double-armed, double-blinded Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042852
Enrollment
20
Registered
2022-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: EpiFAst: SCFAs- Sodium acetate, sodium butyrate, and sodium propionate with complex carbohydrate Cellulose mixture will be used to wound dressing Control Intervention1: Normal Saline: R

Sponsors

Intramural Research Grant AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with chronic ulcer for greater than 4 weeks. Any diabetic foot ulcer Willing and able to provide written informed consent

Exclusion criteria

Exclusion criteria: Subjects who are hypersensitive to complex carbohydrates contents A spreading ulcer in the last 2 weeks before presentation Female subjects who are nursing, pregnant, or planning on becoming pregnant during the study

Design outcomes

Primary

MeasureTime frame
1. EpiFAst will reduce the time of wound healing. 2. EpiFAst will reduce debridement incidence. 3. EpiFAstwill reduce the incidence of infection. 4. EpiFAstwillimprove the quality of life of chronic lower extremity wounds. Timepoint: Before treatment samples (Baseline) and post-treatment sample (15th day)

Secondary

MeasureTime frame
EpiFAst will promote the beneficial microbiome on wound healingTimepoint: Before treatment samples (Baseline) and post-treatment sample (15th day)

Countries

India

Contacts

Public ContactDr Sanjay Giri

AIIMS, Bhubaneswar

plastic_sanjay@aiimsbhubaneswar.edu.in9438894117

Outcome results

None listed

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