Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03061461
• Date of registration: 19/02/2017
• Prospective Registration: Yes
• Primary sponsor: Kuala Lumpur General Hospital
• Public title: Radial Extracorporeal Shock Wave Therapy for Chronic Soft Tissue Wounds
• Scientific title: A Prospective, Randomized, Double-blind, Placebo Controlled, Parallel Group, Single Center Trial to Assess the Efficacy and Safety of Radial Extracorporeal Shock Wave Therapy in Subjects With Chronic Soft Tissue Wounds
• Date of first enrolment: February 23, 2017
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03061461
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Malaysia

Contacts

• Name: Karina Koh, MD

• Name: Harikrishna KR Nair, MD
• Affiliation: Hospital Kuala Lumpur, Malaysia

• Name: Harikrishna KR Nair, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- adults (both male and female) with chronic soft tissue wounds

- age range: between 18 and 80 years

- willingness of the patient to participate in the study, and written informed consent
signed and personally dated by the patient

- different kinds of chronic soft tissue wounds: diabetic foot ulcers, post traumatic,
venous stasis ulcer, decubitus

- wounds scored as Grade/Stage 1A, 1C, 2A and 2C according to Armstrong et al. (Diabetes
Care 1998;21:855-859)

- No contraindications for rESWT

Exclusion Criteria:

- children and teenagers below the age of 18

- no willingness of the patient to participate in the study, and/or written informed
consent not signed and not personally dated by the patient

- wounds scored as Grade/Stage 0A, 0B, 0C, 0D, 1B, 1D, 2B, 2D, 3A, 3B, 3C or 3D
according to Armstrong et al. (1998)

- Burn wounds

- Uncontrolled diabetes because glycaemic control is crucial for wound healing and
erratic values will effect the study results

- Blood sugar levels of the patient before meals are NOT regularly higher than 7mmol/L
and are NOT regularly higher than 11mmol/L one to two hours after meals)

- Contraindications of rESWT: treatment of (i) soft tissue wounds over air-filled tissue
(lung, gut), (ii) pregnant patients, (iii) patients with blood-clotting disorders
(including local thrombosis), (iv) patients treated with oral anticoagulations, (v)
soft tissue wounds above local tumors, and (vi) patients treated with local
corticosteroid applications in the time period of six weeks before the first rESWT
session (if applicable).



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Wound of Skin

Intervention(s)

Device: rESWT

Device: Sham rESWT

Primary Outcome(s)

Wound size [Time Frame: Three months after start of the treatments]

Secondary Outcome(s)

Comfort during treatment [Time Frame: Immediately after each treatment session]

Satisfaction [Time Frame: Three months after start of the treatments]

Pain intensity during treatment [Time Frame: Immediately after each treatment session]

Secondary ID(s)

NMRR-16-1660-32178 (IIR)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors