NCT05849701

Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Diabetic Foot Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-10
• Primary completion: 2023-02-14
• Completion: 2023-04-15
• First posted: 2023-05-09
• Last updated: 2023-05-09

Locations

1 site across 1 country: Egypt