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Clinical Trial Procedure Restores Blood Flow, Easing Patient’s Foot Pain

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Linda McClain at home after LimFlow treatment.
Linda McClain

Linda McClain of Lancaster, Ohio, enjoys going to the salon, grabbing lunch with her friends and line dancing. But in 2018, a diabetic ulcer appeared on her toe and wouldn’t go away. It caused pain and kept her from being active.

After several failed procedures at another hospital, circulation to her left foot couldn’t be restored.

“It was really hard when the toes started to turn black. There wasn’t any blood flow to my foot. It was cold all the time and I just had a lot of pain,” Linda says.

She was headed toward a below-the-knee amputation, which would sideline her from line dancing and other activities forever.

Instead, in April 2020 she found UH interventional cardiologist Mehdi Shishehbor, DO, MPH, PhD. Linda was approved to participate in the LimFlow clinical trial and underwent the procedure in June.

UH Cleveland Medical Center is the only site in Ohio offering this procedure through the clinical trial. LimFlow is a minimally invasive treatment that uses a unique device to disable valves in the vein, reversing flow in the vein so that blood can flow down to the foot. Dr. Shishehbor, the national principal investigator for the trial, successfully restored circulation. Her foot warmed and eventually healed. Her pain dissipated.

Unfortunately, Linda’s toes were too badly damaged and needed to be amputated. But with an orthotic, she can now walk on her own with no pain. For Linda, the three-hour drive to Cleveland for appointments has been well worth it. She credits Dr. Shishehbor and the LimFlow procedure for saving her left foot and leg.

“I finally have hope. I’m going back to line dancing and going back to lunch with my friends. I get around the house better,” she says. “I’m so thankful to Dr. Shishehbor. My pain is greatly decreased and I have more independence. I would urge anyone to get a second opinion before amputation. I’m so glad I did.”

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