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| Name | Class |
|---|---|
| Kafrelsheikh University | OTHER |
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This study will be a randomized, open-label, pretest post-test with two study groups.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 two weeks of intervention. |
| Wound surface area |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaimaa Mohamed Ahmed El Sayeh | Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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Randomized controlled trial
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|
| 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. |
|
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using the ruler method to to measure the longest length and the widest width and multiplying them.
| 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. | 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. | change from baseline and after four weeks of intervention. |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004322 | Drainage |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |