Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05849701

Enrollment

Registered

2023-05-09

Start date

2023-03-10

Completion date

2025-12-15

Last updated

2026-07-13

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

Conditions

Chronic Diabetic Foot Ulcer

Keywords

Shock wave therapy, vacuum-assisted closure, Chronic diabetic foot ulcer

Brief summary

This study will be a randomized, open-label, pretest post-test with two study groups.

Detailed description

The randomization procedure will be performed by a simple drawing of lots (A or B) which determined whether participants would receive Shock wave therapy ( group A) or vacuum-assisted closure therapy (group B). Patients in both groups will receive the same medical treatment and nursing care.

Interventions

DEVICEShock wave therapy

using gymna Shock Master 500 with an input voltage of alternating current (AC) 220 Volte, 100 pulses at 0.13 m joule/mm at 3 Hz per session for 6 weeks.

DEVICEVacuum-assisted closure

Using KCI's Vacuum Assisted Closure Device for six weeks, the pump delivered an intermittent negative pressure of -125 mmHg. The cycle was of seven minutes during which the pump was on for five minutes and off for two minutes, the dressings were changed on the fourth day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Inclusion criteria

All patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence.

Exclusion criteria

Patients with acute cellulitis, osteomyelitis, or gangrene anywhere in the affected extremity. Patients with renal, hepatic, neurological, or malignant diseases. Patients with severe protein malnutrition (serum albumin \< 2.0 g/dl) or severe anemia (Hgb \< 7.0 g/dl). Patients with an ankle-brachial index \< 0.7, absence of the dorsalis pedis or posterior tibial artery pulse. Patients who had debridement; pregnancy. Patients who refused to join the study, or to sign the written consent.

Design outcomes

Primary

Measure	Time frame	Description
Wound surface area	change from baseline and after six weeks of intervention.	using the ruler method to to measure the longest length and the widest width and multiplying them.
Wound volume	change from baseline and after six weeks of intervention.	using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.

Secondary

Measure	Time frame	Description
Wound surface area	change from baseline and after two weeks of intervention.	using the ruler method to to measure the longest length and the widest width and multiplying them.
Wound volume	change from baseline and after two weeks of intervention.	using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORShaimaa MA El Sayeh, PhD

Lecturer at Faculty of Physical Therapy, Cairo University

PRINCIPAL_INVESTIGATORNesrein A Abdel Rashed, PhD

Assistant Professor at Faculty of Physical Therapy, Cairo University

PRINCIPAL_INVESTIGATORHamada A Hamada, PhD