P.E.M.F. Therapy of Chronic Wounds

Launched by PEMF SYSTEMS, INC. · Aug 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of pulsed electromagnetic fields (PEMF) therapy to help heal chronic wounds. Chronic wounds are injuries that do not heal properly and can cause ongoing pain and discomfort. The researchers aim to find out if adding PEMF therapy to standard wound care can improve healing for people with certain types of chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers.

To be eligible for this trial, participants must be at least 21 years old and have an ulcer that has been present for at least six weeks, with a size between 2.0 and 30.0 cm². The trial is open to both men and women, but those with wounds caused by autoimmune diseases or other specific conditions may not qualify. If you participate, you can expect to receive treatment with the PEMF device placed directly on your wound, along with regular evaluations to check on your healing progress. It's important to know that this trial is not yet recruiting participants, so keep an eye out for updates if you or someone you know is interested in this treatment option.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Age must be at least 21 years old at the time of signing consent. 8.2 The index study ulcer size must be between 2.0 and 30.0 cm2 at the time of randomization. Measurements and photographs will to be taken after sharp debridement if performed at the Randomization Visit.
• • The index ulcer must have been present for at least 6 weeks prior to randomization.
• • If more than one ulcer is present on the target limb, the largest eligible ulcer should be deemed the study ulcer. Other ulcers close to the study ulcer are allowed and may be of any size. However, they should be \> 2cm away from the study ulcer. Ulcers are allowed at other locations such as the on the contralateral limb. Other ulcers present besides the index study wound can be treated with different local care but cannot be treated with the PEMF device.
• • Only one site of application of the PEMF device is allowed and the PEMF device must be placed directly over the study ulcer.
• • Subjects to be enrolled into the VLU group must have had a duplex ultrasound study (if not done within six months prior the first screening visit) to document venous disease (deep system obstruction or reflux \> 0.5 sec, or superficial system reflux \> 0.5 sec, or have the characteristic hyperpigmentation and skin changes (lipodermatosclerosis) typical of venous disease.
• • Diabetic Foot Ulcer (DFU): Subjects should have with neuropathy demonstrated by monofilament testing and have Wagner grade 1 wounds without involvement of tendon, bone, or joint.
• • Pressure Ulcer (PU): PU subject wounds must be stage 3 without deep structure involvement such as bone, tendon, or joint.
• • Exclusion Criteria
• • Wounds due to autoimmune disease such as rheumatoid arthritis or vasculitis.
• • Exposed structures deep to the adipose layer of skin such as muscle, fascia, tendon, joint, or bone.
• • The presence of sinus tracts that have not been sufficiently marsupialized such that the wound depth cannot be assessed by gross visual inspection is an exclusion.