Negative Pressure Wound Therapy in Diabetic Wounds

NCT05041244 | Completed

• 1 other identifier: 50/14.2.2018
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Negative pressure wound therapy, diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• Wound closure

  Any wound closure or % reduction in size

  3 weeks

Secondary Outcomes (3)

• Biomarkers

  3 weeks

• complete wound closure

  1 year

• Adverse events

  1 year

Study Arms (2)

Interventional arm

EXPERIMENTAL

NPWT will be delivered through devices (ActiVac and InfoVac) according to FDA protocol in conjunction with the polyurethane foams. Dressing changed will be on a weekly basis.

Device: Negative pressure wound therapy delivered through VAC

Control

OTHER

Standard of care Participants will be given the standard care provided in specialist foot care clinics or in-patients.

Device: Standard of care

Interventions

Negative pressure wound therapy delivered through VAC DEVICE

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)

Interventional arm

Standard of care DEVICE

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.

Also known as: Hydrogel, foams, pad and other dressings

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 - 75 years
• In good general health as evidenced by medical history or diagnosed with diabetes mellitus or exhibiting signs of diabetic foot ulcers
• Patients suffering from diabetic foot ulcer last more than 3 weeks
• Patients with diabetes and presence of a foot wound for more than 3 weeks

You may not qualify if:

• Patients under \<18 years or above 75 years
• Patients unable to provide consent
• Patients suffering from chronic kidney disease or liver impairment or other chronic conditions
• Patients on anticoagulants
• Patients with non diabetic ulcers
• Patients with severe peripheral vascular disease
• Patients having contra-indication to negative pressure wound therapy

Sponsors & Collaborators

• University of Mauritius: lead
• Ministry of Health and Wellness, Mauritius: collaborator
• Higher Education Commission, Mauritius: collaborator
• Acelity: collaborator

Study Sites (1)

University of Mauritius

Réduit, Moka District, 80837, Mauritius

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Abha Jodheea-Jutton, MBBS MRCGP

  University of Mauritius

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Superiority, multi-centre randomised parallel groups

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 13, 2021
• Study Start: May 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)