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Chronic non healing ulcer and bacteriophage therapy

A randomized, placebo controlled, double blind clinical trial of therapeutic bacteriophage preparation in chronic antibiotic-resistant wound infections. - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038527
Enrollment
46
Registered
2021-12-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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: Customized Bacteriophage preparation: Customized bacteriophage preparation with conc. of phages 9log 10/ml would be administered topically on every alternate day till wound surface beco

Sponsors

Prof Gopal Nath
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Males or females from 12 to 70 years, with or without type 1 or type 2 diabetes and a chronic, (present for at least 6 weeks) full-thickness ulcer not penetrating to the tendon, periosteum, or bone, and with a cross-sectional area between 25 and 2,500 mm2. Participants will be required to have either a palpable pedal pulse or an ankle-brachial pressure index (ABPI) of > 0.5. Participants with ulcer infection. Written informed consent

Exclusion criteria

Exclusion criteria: Burn patients malignant ulcers ulcers due to systemic diseases except for diabetes mellitus ulcers due to arterial diseases Ulcers due to skin disorders Patients not giving consent

Design outcomes

Primary

MeasureTime frame
Efficacy of customized phage therapy as assessed by the % ulcer reduction by using Bates Jensen Criteria.Timepoint: 4 weeks

Secondary

MeasureTime frame
Until healthy granulation tissue formed or 12 weeks period or complete healingTimepoint: After follow up

Countries

India

Contacts

Public ContactSubhash Lal Karn

Institute of Medical Sciences, Banaras Hindu University

gopalnath@gmail.com9335058394

Outcome results

None listed

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