MedTrace Logo

Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds

NCT03061461 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-02-24

No results posted yet for this study

Summary

This study tests the hypothesis that radial extracorporeal shock wave therapy (rESWT) as performed by Zoech (JATROS Orthop 2009;(1):46-47) is effective and safe in treatment of chronic soft tissue wounds, and is statistically significantly more effective than sham-treatment of chronic soft tissue wounds.

Conditions

  • Wound of Skin

Interventions

DEVICE

rESWT

All patients will receive standard care as follows: 1. Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with rESWT. 4. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin, Smith \& Nephew, Inc. Advanced Wound Management; Fort Worth, TX, USA). In addition, patients in arm "rESWT" will receive rESWT between Steps 2 and 3 of standard care as outlined in arm description "rESWT".

DEVICE

Sham rESWT

All patients will receive standard care as follows: 1. Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee. 2. The clean wounds will be assessed using the TIME concept. 3. Treatment with sham rESWT. 4. Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin). In addition, patients in arm "Sham rESWT" will receive sham rESWT between Steps 2 and 3 of standard care as outlined in arm description "Sham rESWT".

Sponsors & Collaborators

  • Kuala Lumpur General Hospital

    lead OTHER_GOV

Principal Investigators

  • Harikrishna KR Nair, MD · Hospital Kuala Lumpur, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2017-12-15
Completion
2017-12-15
FDA Device
Yes

Countries

  • Malaysia

Study Locations

More Related Trials

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 NCT03061461 on ClinicalTrials.gov