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Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

NCT05849701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-09

No results posted yet for this study

Summary

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

Conditions

  • Chronic Diabetic Foot Ulcer

Interventions

DEVICE

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 6 weeks.

DEVICE

Vacuum-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.

Sponsors & Collaborators

  • Kafrelsheikh University

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Shaimaa MA El Sayeh, PhD · Lecturer at Faculty of Physical Therapy, Cairo University

  • Nesrein A Abdel Rashed, PhD · Assistant Professor at Faculty of Physical Therapy, Cairo University

  • Hamada A Hamada, PhD · Assistant Professor at Faculty of Physical Therapy, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2023-02-14
Completion
2023-04-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849701 on ClinicalTrials.gov