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Completed

NCT Number: NCT05849701

Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

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

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Key information

Conditions

Chronic Diabetic Foot Ulcer

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaimaa Mohamed Ahmed El Sayeh

Cairo, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shock Wave Therapy

Device

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.

Other names: Traditional medical and wound care

Vacuum-assisted closure

Device

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.

Other names: Traditional medical and wound care

Primary outcomes

  1. Wound surface area

    Time frame: 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.

  2. Wound volume

    Time frame: 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 outcomes

  1. Wound surface area

    Time frame: 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.

  2. Wound surface area

    Time frame: change from baseline and after four weeks of intervention.

    using the ruler method to to measure the longest length and the widest width and multiplying them.

  3. Wound volume

    Time frame: 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.

  4. Wound volume

    Time frame: change from baseline and after four weeks of intervention.

    using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kafrelsheikh University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 9, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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