Chronic Diabetic Foot UlcerNCT05849701
Shock Wave Versus Vacuum Assisted Closure on Chronic Diabetic Foot Ulcer
A study testing Shock wave therapy and Vacuum-assisted closure in people with Chronic Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be a randomized, open-label, pretest post-test with two study groups. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Diabetic Foot Ulcer
- What is being tested?
- Shock wave therapy and Vacuum-assisted closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer
This study will be a randomized, open-label, pretest post-test with two study groups.
Read the 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.
- Conditions
- Chronic Diabetic Foot Ulcer
- Being tested
- Shock wave therapy, Vacuum-assisted closure
- Keywords
- Shock wave therapy, vacuum-assisted closure, Chronic diabetic foot ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wave therapyDevice
Also called Traditional medical and wound care
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
Also called Traditional medical and wound care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Vacuum-assisted closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound surface area
using the ruler method to to measure the longest length and the widest width and multiplying them.
Measured: 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.
Measured: change from baseline and after six weeks of intervention.
Secondary outcomes (4)
Wound surface area
using the ruler method to to measure the longest length and the widest width and multiplying them.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline and after four weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start10 Mar 2023
- Primary completion14 Sep 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa MA El Sayeh, PhD, Principal investigator, Lecturer at Faculty of Physical Therapy, Cairo UniversityNesrein A Abdel Rashed, PhD, Principal investigator, Assistant Professor at Faculty of Physical Therapy, Cairo UniversityHamada A Hamada, PhD, Principal investigator, Assistant Professor at Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849701
- Sponsor's protocol ID
- P.T/INTG/3/2023/45
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Versus Vacuum-assisted Closure on Chronic Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT05849701
- Acronym / sponsor ID
- P.T/INTG/3/2023/45
- Conditions
- Chronic Diabetic Foot Ulcer
- Keywords
- Shock wave therapy, vacuum-assisted closure, Chronic diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 14 Sep 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Shock wave therapy group | Active comparator | Device: Shock wave therapyPatients 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 |
| Vacuum-assisted closure group | Active comparator | Device: Vacuum-assisted closurethe 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients had chronic diabetic foot ulcers that did not heal within six weeks of the incidence.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shock wave therapyAlso: Traditional medical and wound careusing 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. | Device | Shock wave therapy group |
| Vacuum-assisted closureAlso: Traditional medical and wound careUsing 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. | Device | Vacuum-assisted closure group |
Primary outcome
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.
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.
4 secondary outcomes
Wound surface area
Time frame: change from baseline and after two weeks of intervention.
Wound surface area
Time frame: change from baseline and after four weeks of intervention.
Wound volume
Time frame: change from baseline and after two weeks of intervention.
Wound volume
Time frame: change from baseline and after four weeks of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruiting
Subcutaneous Dexpanthenol Administration and Wound Epithelialization
Chronic Wounds, Diabetic Foot Ulcer
RecruitingPhase 3
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaimaa MA El Sayeh, PhD principal investigator
Lecturer at Faculty of Physical Therapy, Cairo University
Nesrein A Abdel Rashed, PhD principal investigator
Assistant Professor at Faculty of Physical Therapy, Cairo University
Hamada A Hamada, PhD principal investigator
Assistant Professor at Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock wave therapy and Vacuum-assisted closure in people with Chronic Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound surface area (time frame: change from baseline and after six weeks of intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.