Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2023-04-15

Brief Summary

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

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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.

Conditions

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Chronic Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Shock wave therapy

Intervention Type DEVICE

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 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.

Group Type ACTIVE_COMPARATOR

Vacuum-assisted closure

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Traditional medical and wound care Traditional medical and wound care

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No