Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

Cairo University90 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Diabetic Foot Ulcer

Interventions

Shock wave therapyDEVICE

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 closureDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shaimaa Mohamed Ahmed El Sayeh

Cairo, Egypt

Outcomes

Primary Outcomes

Wound surface area

using the ruler method to to measure the longest length and the widest width and multiplying them.

Time frame: 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.

Time frame: change from baseline and after six weeks of intervention.

Secondary Outcomes

Wound surface area

using the ruler method to to measure the longest length and the widest width and multiplying them.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: change from baseline and after four weeks of intervention.

Data from ClinicalTrials.gov

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