Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Wound volume
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Shock wave therapy (Device)
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.
Intervention: Vacuum-assisted closure (Device)
Outcomes
Primary Outcomes
Wound volume
Time Frame: change from baseline and after six weeks of intervention.
using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.
Wound surface area
Time Frame: change from baseline and after six weeks of intervention.
using the ruler method to to measure the longest length and the widest width and multiplying them.
Secondary Outcomes
- Wound surface area(change from baseline and after four weeks of intervention.)
- Wound volume(change from baseline and after four weeks of intervention.)
- Wound surface area(change from baseline and after two weeks of intervention.)
- Wound volume(change from baseline and after two weeks of intervention.)
Investigators
Shaimaa Mohamed Ahmed Elsayeh
Lecturer of physical therapy
Cairo University