Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

Chronic Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849701
• Other study ID #: P.T/INTG/3/2023/45
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 15, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcer
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Shaimaa Mohamed Ahmed El Sayeh	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.