Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05849701
• Collaborator: Kafrelsheikh University (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Diabetic Foot Ulcer	Device: Shock wave therapy; Device: Vacuum-assisted closure	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trialRandomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer
• Actual Study Start Date: Mar 10, 2022
• Actual Primary Completion Date: Feb 14, 2023
• Actual Study Completion Date: Apr 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. Wound surface area [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaimaa Mohamed Ahmed El Sayeh	Cairo		Egypt	02

Sponsors and Collaborators

• Cairo University
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaimaa Mohamed Ahmed Elsayeh, Lecturer of physical therapy, Cairo University
• ClinicalTrials.gov Identifier: NCT05849701
• Other Study ID Numbers: P.T/INTG/3/2023/45
• First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shaimaa Mohamed Ahmed Elsayeh, Lecturer of physical therapy, Cairo University: Shock wave therapy; vacuum-assisted closure; Chronic diabetic foot ulcer
• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer

Study Results

No Results Posted as of May 9, 2023