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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006236

Enrollment

Registered

2014-06-18

Start date

2015-04-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10.74 E14

Interventions

Group 1: Standard therapy complemented Shock Wave Therapy. In this trial the standard treatment of the diabetic foot syndrome is complemented by shock wave therapy to improve the wound healing. By t

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

Exclusion criteria: -Presence of an ABI (=Ankle Brachial Index) of 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

Design outcomes

Primary

Measure	Time frame
Assessment whether ESWT with the linear focused device FBL10x5G2 improves secondary wound healing: - measurement of the wound area by photo planimetry (in % and mm2) - 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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactBernd Jänigen

Abteilung für Allgemein und Viszeralchirurgie Chirurgische Universitätsklinik Freiburg

bernd.jaenigen@uniklinik-freiburg.de+49 761 270-27690

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026