Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer

NCT05849701 | Completed

• 1 other identifier: P.T/INTG/3/2023/45
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Diabetic Foot Ulcer

Keywords

Shock wave therapy; vacuum-assisted closure; Chronic diabetic foot ulcer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Wound surface area

  change from baseline and after two weeks of intervention.

• Wound surface area

  change from baseline and after four weeks of intervention.

• Wound volume

  change from baseline and after two weeks of intervention.

• Wound volume

  change from baseline and after four weeks of intervention.

Study Arms (2)

Shock wave therapy group

ACTIVE COMPARATOR

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

Vacuum-assisted closure group

ACTIVE COMPARATOR

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

Interventions

Shock wave therapy 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.

Also known as: Traditional medical and wound care

Shock wave therapy group

Vacuum-assisted closure 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.

Also known as: Traditional medical and wound care

Vacuum-assisted closure group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

Shaimaa Mohamed Ahmed El Sayeh

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Drainage; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Shaimaa MA El Sayeh, PhD

  Lecturer at Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

• Nesrein A Abdel Rashed, PhD

  Assistant Professor at Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

• Hamada A Hamada, PhD

  Assistant Professor at Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 9, 2023
• Study Start: March 10, 2022
• Primary Completion: February 14, 2023
• Study Completion: April 15, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)