Open sores that won't heal are a common but dangerous condition that many diabetics face.
Cleveland Foot and Ankle Clinic is looking for study participants to test a new treatment that uses "fresh" amniotic tissue to promote faster healing.
44-year-old Jayne Reed of Old Brooklyn managed her Type 1 Diabetes since the day she was diagnosed at age 14. But last May, she developed a friction ulcer on her foot. It healed mostly all the way except for a pin hole size opening.
Jayne woke up the next morning and her foot was swollen and she knew something was very wrong. It seemed the foot became infected almost overnight.
“It was aggressive and it could have taken me out in 24 hours, is what I was told, I could have died in 24 hours had I not gone to the emergency room,” Jayne says.
The infection spread so fast Jayne developed gangrene and the only option to save her life was amputation. At the very same time, Jayne was diagnosed with Lupus. An autoimmune disorder.
Because she was immunocompromised from both the diabetes and lupus, the surgical wound wasn't healing and stayed that way for more than six months.
Three months ago Jayne became the first patient enrolled in an FDA trial of a new product called Affinity by Organogenesis. It’s “fresh” amniotic tissue being tested to see if it can promote faster wound healing.
Dr. Windy Cole is director of wound care at Cleveland Foot and Ankle Clinic at 7000 Euclid Ave. in Cleveland. The clinic is also used as a teaching facility for Kent State University’s College of Podiatric Medicine.
Dr. Cole says dehydrated and frozen amniotic tissue is already in use for treating diabetic foot wounds, but fresh may be better.
“These are mesenchymal stem cells that give us much more healing power than what's currently out there in the market,” Dr. Cole says.
After three months of treatment, Jayne saw an 80% improvement in her wound.
“I consider myself the worst case scenario so whoever is not the worst case scenario should probably do better,” she said.
The tissue is donated by pre-screened women who undergo cesarean section birth. The placenta is collected and then tested again for any bacteria. Then it’s put into a container with a solution that allows it to free float and provides nutrients, which is what keeps it fresh.
The tissue is placed directly onto the open wound where it actually spreads out to cover more. Then the patient is bandaged up and will return in a week for another treatment.
Faster healing is critical. Dr. Cole says studies show mortality rates increase 50-70% in diabetic patients who go through amputation.
“So by healing patients faster, salvaging their limbs and preventing amputation we are saving lives,” Dr. Cole says.
The study is looking for diabetic patients over the age of 18 who have an uninfected but slow healing wound. Those who are uninsured and underinsured are encouraged to respond. For more information Click HERE.