Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

Cairo University (CU)

Status: Completed

Conditions: Chronic Diabetic Foot Ulcer

Treatments: Device: Vacuum-assisted closure; Device: Shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05849701

P.T/INTG/3/2023/45

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Shock wave therapy group

Active Comparator group

Description:

Patients in this group were managed by shock 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 six weeks

Treatment:

Device: Shock wave therapy

Vacuum-assisted closure group

Active Comparator group

Description:

the patients in this group were treated by vacuum-assisted closure using KCI's Vacuum Assisted Closure Device, 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.

Treatment:

Device: Vacuum-assisted closure