Evaluation of a nitric oxide generating dressing (EDX110) to improve management of Buruli ulcer disease (BURULINOX)

Phase 3

Recruiting

• Conditions: Skin and Connective Tissue Diseases

• Registration Number: PACTR201812819039144
• Lead Sponsor: Kumasi Centre for Collaborative Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-18
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

i.Male or female patients aged between 5 years and 80 years inclusive.
ii.Buruli lesion (ulcer, nodule or plaque) iii.The lesion must have been tested positive for M. ulcerans by PCR for IS2404
iv.Able to give informed consent/assent for minors.
v.Able and willing (or have parents/carers able and willing) to follow the protocol requirements

Exclusion Criteria

i.Female patients who are pregnant or breast-feeding.
ii.Any other serious disease likely to compromise the outcome of the trial.
iii.Participation in any interventional study during the 2 weeks (or 5 half-lives of the investigational product, if longer) preceding the intervention period of the study.
iv.Currently taking antibiotics that could interact with the trial medication.
v.Known allergy to any of the oral antibiotics or components of EDX dressing

Study & Design

• Study Type: Interventional
• Study Design: Not specified