Frequency Rhythmic Electrical Modulated Stimulation Therapy in Chronic Ulcers.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FREMS.
- Who it may be relevant to
- Registry conditions: Chronic Ulcers. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Chronic Ulcer Healing With Frequency Rhythmic Electrical Modulated Stimulation (FREMS)Therapy and Phenytoin Application in Diabetic Patients.
Overview
The goal of the study is to 1. To measure wound size of chronic ulcers after using FREMS therapy and phenytoin application in the interventional group monthly till the end of the third month compared to baseline. 2. To measure wound size of chronic ulcers after using standard of care in control group monthly till the end of the third month compared to baseline. 3. To compare the results of the 2 groups and determine the significance of the treatment.
Detailed description
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.
Interventions
- Device FREMS
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.
Primary outcome measures
- healing rate [Time frame: measuring once a month for 3 months.]
Eligibility criteria
Inclusion criteria
- chronic ulcers more than 3 months.
Exclusion criteria
- incapable of being in the clinic of diabetic ulcer during treatment period 3 days/ week for 3 months.
- severe ischemia that is indicated for a surgery.
- infection or osteomyelitis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National diabetes institute — Giza
Publications
- 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. PMID 24142074
Identifiers
NCT: NCT07645495 · IDE00360