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| Name | Class |
|---|---|
| General Organization for Teaching Hospitals and Institutes | OTHER |
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The goal of the study is to
Wound ulcers including diabetic foot ulcers impose a substantial and escalating economic burden on healthcare systems worldwide. In the United States alone, chronic wounds affect over 10 million people and account for annual healthcare costs ranging from $28.1 to $96.8 billion. Major challenges persist, including antibiotic resistance, high recurrence rates, delayed healing in patients with comorbidities, and limited evidence for many advanced therapies. Additionally, cost, access to specialized care, and the need for individualized, multidisciplinary management remain significant barriers to optimal outcomes. Using two effective modalities in cases that are resistant to all known treatments, whether they are conservative or adjuvant, is a promising technique to end the entrapment of a wound in a certain stage and avoid complications like further amputation. enrolled patients will be randomly assigned to one of either groups Group A: Intervention group that will receive 3 sessions /week of FERM with phenytoin application with spraying phenytoin topical 40 mg spray after each session according to ulcer size to cover the ulcer.
Group B: Control group that will receive standard of care and will be assessed at baseline and every month till they completed 3 months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronic ulcers patients | Experimental | FREMS therapy 3 sessions/week for 40 minutes with phenytoin spray 40mg. |
|
| ulcers patients | No Intervention | control group: SOC(debridement and basic wound care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FREMS | Device | frequency rhythmic electrical stimulation which is an electrical device specialized in diabetes complications like ulcers and neuropathies, with proven efficacy in neuropathies, and promising results in ulcers. |
| Measure | Description | Time Frame |
|---|---|---|
| healing rate | wound size | measuring once a month for 3 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibtihal Nassar, Msc. | Contact | +201151678506 | ibtihalnassar@gothi.gov.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National diabetes institute | Giza | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24142074 | Background | Magnoni C, Rossi E, Fiorentini C, Baggio A, Ferrari B, Alberto G. Electrical stimulation as adjuvant treatment for chronic leg ulcers of different aetiology: an RCT. J Wound Care. 2013 Oct;22(10):525-6, 528-33. doi: 10.12968/jowc.2013.22.10.525. |
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