Back to resultsShock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
Primary Purpose
Chronic Diabetic Foot Ulcer
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Shock wave therapy
Vacuum-assisted closure
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Diabetic Foot Ulcer focused on measuring Shock wave therapy, vacuum-assisted closure, Chronic diabetic foot ulcer
Eligibility Criteria
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.
Sites / Locations
- Shaimaa Mohamed Ahmed El Sayeh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Shock wave therapy group
Vacuum-assisted closure group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Wound surface area
using the ruler method to to measure the longest length and the widest width and multiplying them.
Wound volume
using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.
Secondary Outcome Measures
Wound surface area
using the ruler method to to measure the longest length and the widest width and multiplying them.
Wound surface area
using the ruler method to to measure the longest length and the widest width and multiplying them.
Wound volume
using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.
Wound volume
using the ruler method to to measure the longest length, the widest width and the deepest area multiplying them.
Full Information
NCT ID
NCT05849701
First Posted
April 24, 2023
Last Updated
May 5, 2023
Sponsor
Cairo University
Collaborators
Kafrelsheikh University
1. Study Identification
Unique Protocol Identification Number
NCT05849701
Brief Title
Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
Official Title
Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diabetic Foot Ulcer
Keywords
Shock wave therapy, vacuum-assisted closure, Chronic diabetic foot ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shock wave therapy group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Vacuum-assisted closure group
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Shock wave therapy
Other Intervention Name(s)
Traditional medical and wound care
Intervention Description
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
Intervention Name(s)
Vacuum-assisted closure
Other Intervention Name(s)
Traditional medical and wound care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound surface area
Description
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.
Title
Wound volume
Description
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 Outcome Measure Information:
Title
Wound surface area
Description
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.
Title
Wound surface area
Description
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.
Title
Wound volume
Description
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.
Title
Wound volume
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa MA El Sayeh, PhD
Organizational Affiliation
Lecturer at Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nesrein A Abdel Rashed, PhD
Organizational Affiliation
Assistant Professor at Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hamada A Hamada, PhD
Organizational Affiliation
Assistant Professor at Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaimaa Mohamed Ahmed El Sayeh
City
Cairo
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
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