Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer

Not Applicable

• Conditions: Venous Leg Ulcer
• Interventions: Combination Product: electromagnetic field and a plantar resistance exercise; Device: Pulsed electromagnetic field; Other: usual care

• Registration Number: NCT05410613
• Lead Sponsor: Mona Mohamed Taha

Brief Summary

The purpose of this study will investigate the effects of combined electromagnetic field and a plantar resistance exercise therapy versus electromagnetic field on healing of venous leg ulcer .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-03-14
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-05
• Last Update Submitted: 2022-06-05
• Study First Posted: 2022-06-08
• Last Update Posted: 2022-06-08
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

patients with venous leg ulcer

Exclusion Criteria

patients who have one or more of the following conditions:

• peripheral vascular disease (PVD), (ABPI<0.8).
• venous leg ulcers with cellulitis or infection symptoms, as well as venous leg ulcers with necrotic tissue or slough or had more than one ulcer.
• other types of ulcers, such as rheumatoid vasculitis, diabetic foot, and malignant ulceration; corticosteroids use ; patients with dementia or who were disoriented;
• undertaken another physical therapy modality for ulcer healing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined electromagnetic field and a plantar resistance	electromagnetic field and a plantar resistance exercise	-
electromagnetic field	Pulsed electromagnetic field	-
conservative treatment for the ulcer	usual care	-

Primary Outcome Measures

Name	Time	Method
Ulcer volume measurement	two months	Ulcer volume : The ulcer would be traced on transparent paper and placed over the metric graph paper to have the longest length and width.; * A disposable measuring tape would be directed into the deepest point of the ulcer to record the ulcer depth.; * (Width x length x depth) would be calculated to have the volume of the ulcer
Pressure Ulcer Scale for Healing (PUSH)	two months	Categorize the ulcer with respect to surface area, exudate, and type of wound tissue
Ulcer surface area	two months	Ulcer surface (UAS) would be calculated by placing a piece of sterilized transparency film over the ulcer and tracing the ulcer perimeter on the film with fine tipped transparency marker.

Trial Locations

Locations (1)

Surgical department-Mansoura Health Insurance Hospital; 🇪🇬 Mansoura, Egypt