Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

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.

Study Overview

• Status: Completed
• Conditions: Chronic Diabetic Foot Ulcer
• Intervention / Treatment: Device: Shock wave therapy; Device: Vacuum-assisted closure

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Shaimaa Mohamed Ahmed El Sayeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Shock wave therapy group; 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	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.; Other Names: Traditional medical and wound care
Active Comparator: Vacuum-assisted closure group; 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.	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.; Other Names: Traditional medical and wound care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Kafrelsheikh University
• Investigators: Principal Investigator: Shaimaa MA El Sayeh, PhD, Lecturer at Faculty of Physical Therapy, Cairo University; Principal Investigator: Nesrein A Abdel Rashed, PhD, Assistant Professor at Faculty of Physical Therapy, Cairo University; Principal Investigator: Hamada A Hamada, PhD, Assistant Professor at Faculty of Physical Therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Shock wave therapy; vacuum-assisted closure; Chronic diabetic foot ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: P.T/INTG/3/2023/45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No