Frequency Rhythmic Electrical Modulated Stimulation Therapy in Chronic Ulcers.

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.

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.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts