Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

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

Detailed Description
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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.

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

Conditions
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Chronic Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Shock wave therapy
* Device: Vacuum-assisted closure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shock wave therapy group<br>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<br>* 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.<br>* Other names: Traditional medical and wound care;|
| Active Comparator: Vacuum-assisted closure group<br>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<br>* 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.<br>* Other names: Traditional medical and wound care;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock wave therapy, vacuum-assisted closure, Chronic diabetic foot ulcer