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Negative Pressure Wound Therapy in Diabetic Wounds

NCT05041244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-13

No results posted yet for this study

Summary

Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment. Patient with DFU will be selected based on an eligible criteria and randomly assigned to intervention group or control group.

Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis A randomised controlled study is being proposed, where up to 100 participants will be recruited.

The wounds of participants in the intervention arm will be managed with 3 weeks of TNPW.

Conditions

  • Diabetic Foot

Interventions

DEVICE

Negative pressure wound therapy delivered through VAC

Initial cycle: Continuous first 48 hours Subsequent cycle: Consider intermittent DPC (5 min ON/2 mins OFF) for rest of the therapy Target Target Pressure: 50-175mmHg, to be titrated for more drainage Dressing change interval: every week; need for more frequent dressing need to be evaluated. More frequent change of adaptic can be considered. (Adaptic is a layer of thin dressing that will be in direct contact with the wound to reduce the risk of maceration and adherence to the dressing)

DEVICE

Standard of care

Participants in the control arm will have their dressings changed as per the current standard of care. Effective management of DFU will depend on accurate diagnosis and assessment and appropriate debridement of non-viable tissues in patients from both arms Patients will be advised to continue off loading and any evidence of early infection should be promptly treated.

Sponsors & Collaborators

  • Ministry of Health and Wellness, Mauritius

    collaborator UNKNOWN

  • Higher Education Commission, Mauritius

    collaborator UNKNOWN

  • Acelity

    collaborator OTHER

  • University of Mauritius

    lead OTHER

Principal Investigators

  • Abha Jodheea-Jutton, MBBS MRCGP · University of Mauritius

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-03-01
Completion
2021-07-01

Countries

  • Mauritius

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041244 on ClinicalTrials.gov