Extracorporeal Shock Wave Therapy for secondary wound healing of diabetic foot syndrome – ESWT

Not Applicable

• Conditions: E10.74; E14; Unspecified diabetes mellitus

• Registration Number: DRKS00006236
• Lead Sponsor: eitender Ärztliche Direktor Universitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-18
• Study Completion: 2018-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

patients with diabetic foot syndrome:
-chronic wound since at least 4 weeks
- Wagner stage 1-2
-ABI (ankle-brachial-index) 0.7-1.2
- Patients with Diabetic mellitus receive a therpaiy HbA1c<=7,5%
- appropriate pressure relief
General inclusion criteria:
-signed declaration of informed consent and data protection
-males and females
-older than 18 years

Exclusion Criteria

-Presence of an ABI (=Ankle Brachial Index) of < 0.7 > 1,2
- patient with malignant disease
- Wagner stage 3-5
- osteitis/Osteomyelitis in wound region
- untreated wound infektion (leukocytes>12 000/miicroliter)
- General exclusion criteria:
- pregnancy
- participation in other clinical studies either concurrently or within the last 30 days
- Noncompliance (Patient does not wear the shoes, does not carry out local therapy or terminates it,
- Evidence of any major life-threatening or serious medical condition (sytemic infection)
- Heart pacemaker and implanted defibrillator

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment whether ESWT with the linear focused device FBL10x5G2 improves secondary wound healing:<br>- measurement of the wound area by photo planimetry (in % and mm2)<br>- analyzing the rate of wound healing as reduction of the lesion divided by the initial area (in percent) in the treatment and follow up period (in %)

Secondary Outcome Measures

Name	Time	Method
- percentage of comlete wound closure .<br>- tissue oxygenation and microvascular blood flow at wound border and within the wound by O2C measurement<br>- tissue temperature of the wound bed outside and within the wound by thermography (IR-Kamera Fluke Ti25).<br>-bactericidal effect: change in microbial count/ swab culture<br>-percentage of change in pain symptoms on VAS scale 1 – 10<br>- increased angiogenesis and increased growth factors in wound biopsy