Do you have a chronic, non-healing wound?
Does it cause you pain and keep you from living your life to the fullest?
If a new treatment were available that might reduce your wound size and associated pain…would you try it?
If you answered YES to these three questions, you may be eligible to join a clinical study, at no additional cost to you, to answer this question: Can microcurrent stimulation reduce wound size and pain experienced by patients with chronic wounds?
What is microcurrent stimulation?
Microcurrent stimulation uses electrical energy that passes into tissue, stimulating internal electrical and chemical processes. The treatment is thought to be effective in improving circulation, accelerating tissue regeneration, and reducing inflammation. What will the study involve?
Microcurrent stimulation will be used as an additional treatment to your current standard of care treatment. The once-a-week visits can be combined with your existing appointments. You can do the rest of the daily treatments in the comfort of your own home. This study will last approximately 4 weeks with one follow up visit 30 days after your final treatment visit. If you complete the study you will be able to keep the microcurrent device if you want.
The microcurrent devices are non-invasive, hand-held, and battery operated. They have been FDA-cleared for pain management. On the reverse side of this brochure is a picture of the device you will be using if you qualify for the study.
If you are interested, please answer yes or no on the following table to see if you qualify as a participant.
INCLUSION CRITERIA (If you answered “yes” to all Inclusion Criteria you may qualify to participate)
- Age ≥40 and ≤70 years o Yes o No
- Has a chronic wound that has not healed in 30 days o Yes o No
- Wound area is ≥0.5 cm2 and ≤22 cm2 o Yes o No
- Willing and able to comply with weekly visits to clinic for 4 weeks with one follow up visit 30 days after the final treatment visit. (e.g., reliable transportation) o Yes o No
- Willing and able to perform microcurrent treatment at home on daily basis o Yes o No
- For females of reproductive potential, a recorded statement that they are not pregnant nor will they become pregnant during the conduct of the study (refer to Informed Consent) o Yes o No
EXCLUSION CRITERIA (If you answered ‘No” to all Exclusion Criteria you may qualify to participate)
- User of any microcurrent device in the past six (6) months prior to enrollment in the study o Yes o No
- Patient is experiencing a medical emergency o Yes o No
- Presence of an electrical implant such as a cardiac pacemaker or neural stimulator o Yes o No
- Patient is diagnosed with hypotension o Yes o No
- Patient is diagnosed with neuropathy from sources other than diabetes, such as heavy metal, xenobiotic toxicity o Yes o No
- Patient is diagnosed with Charcot-Marie-Tooth or similar genetically inheritable neuropathic disease(s) o Yes o No
- Patient is diagnosed with an untreated vitamin deficiency o Yes o No
- Patient is diagnosed with end-stage kidney disease/dialysis or severe kidney insufficiency o Yes o No
- Patient is diagnosed with HIV/AIDS o Yes o No
- Patient exhibits active drug, alcohol or substance abuse o Yes o No
- Patient is diagnosed with malignancies (cancers) undergoing treatment o Yes o No
- Patient has a history of malignancies (in remission or not) with involvement of the musculoskeletal system o Yes o No
- Patient is currently pregnant, possibly pregnant or breast-feeding o Yes o No
- Patient has a BMI ≥40 o Yes o No
The potential benefits of participation are:
- Narcotic-free pain relief: The devices are FDA cleared for pain management.
- Wound healing: The devices use electrical energy that passes into tissue, stimulating internal electrical and chemical processes. The treatment might be effective in improving circulation, accelerating tissue regeneration, and reducing inflammation.
- Mobility: Some patients find that pain and their chronic wound makes daily tasks difficult. The device might cause a reduction in pain and wound size, so that some patients might be able to resume their daily activities.