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)

  1. Age ≥40 and ≤70 years o Yes o No
  2. Has a chronic wound that has not healed in 30 days o Yes o No
  3. Wound area is ≥0.5 cm2 and ≤22 cm2 o Yes o No
  4. 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
  5. Willing and able to perform microcurrent treatment at home on daily basis o Yes o No
  6. 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)

  1. User of any microcurrent device in the past six (6) months prior to enrollment in the study o Yes o No
  2. Patient is experiencing a medical emergency o Yes o No
  3. Presence of an electrical implant such as a cardiac pacemaker or neural stimulator o Yes o No
  4. Patient is diagnosed with hypotension o Yes o No
  5. Patient is diagnosed with neuropathy from sources other than diabetes, such as heavy metal, xenobiotic toxicity o Yes o No
  6. Patient is diagnosed with Charcot-Marie-Tooth or similar genetically inheritable neuropathic disease(s) o Yes o No
  7. Patient is diagnosed with an untreated vitamin deficiency o Yes o No
  8. Patient is diagnosed with end-stage kidney disease/dialysis or severe kidney insufficiency o Yes o No
  9. Patient is diagnosed with HIV/AIDS o Yes o No
  10. Patient exhibits active drug, alcohol or substance abuse o Yes o No
  11. Patient is diagnosed with malignancies (cancers) undergoing treatment o Yes o No
  12. Patient has a history of malignancies (in remission or not) with involvement of the musculoskeletal system o Yes o No
  13. Patient is currently pregnant, possibly pregnant or breast-feeding o Yes o No
  14. 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.
Apply for our Wound Study Clinical Trial
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Protect Against Coronavirus: Doing our Part to Help you

 
In these difficult times we want to share with you some brief bullet-points about Sharlin Health and Neurology and COVID-19:
  • First and foremost, we want you to know that the safety and well-being of each and every one of you is number one importance to us. If you have a chronic lung condition or another health reason that would make you susceptible to the more severe effects of the coronavirus, we want you to stay at home.
  • Sharlin Health and Neurology is considered an “essential” business because we provide critically needed care to those with neurological disease in our community. Despite the threat of the coronavirus conditions like Alzheimer’s, Parkinson’s disease, seizures, migraine, MS, and other neurological diseases do not go away. We are a privately-owned neurology practice here to serve our community.
  • We follow all CDC guidelines for protection against the dissemination of coronavirus. There have not been any known cases of coronavirus in our office, among staff and those customers who have entered our door. 
  • We have six available exam rooms in our clinic and every effort will be made to prevent patients from having to stay in our waiting room. We can move you quickly from the reception desk to a private exam room, and have the doctor meet you there.
  • If you are sequestered at home, it may be possible to visit with you by telemedicine. We have the capability of using a telemedicine portal though the smart phone or computer that is HIPAA compliant and allows us to see you and speak with you. Alternatively, we can speak by telephone. Please ask our receptionist.
  • If you do come to our clinic for a doctor visit or a need a test please do not touch any surfaces you can avoid touching, and come by yourself or – if you do need to have someone with you – have them bring you to the door and we will help you from that point. If they wait in their vehicle, we can call them when you are finished.
  • If you have had contact with a person with known or suspected COVID-19, have had contact with a person coughing or with fever in the past 14 days, or you yourself have a fever, cough, or runny nose in the past 14 days, please let us know and we will either reschedule you or schedule you a telemedicine visit. 

If you think you may have been exposed to COVID-19 please reach out to your nearest medical center. We will not be testing patients at Sharlin Health and Neurology. 

Click Here To Learn More


 
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Despite limited hours for the month of April, we will be checking telephone messages and messages on our patient portal, including prescription refill requests. As always, if you have an emergency please go to your local emergency room or urgent care clinic.
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