News
Dr. Lavor Helps Patient Avoid Amputation with Wharton’s Jelly Allograft
Mar 13, 2024
Charcot foot, a rare and progressive degeneration of the foot and ankle joints, is an infrequent complication in general diabetic populations. Still, its prevalence escalates to 35 percent in diabetic patients with peripheral neuropathy.
Current treatments for Charcot foot are highly debated. The early stages of Charcot foot are usually treated with a cast or special boot to protect the foot and ankle. The goal of casting is to allow the bones to heal in a stable position and prevent further deformities from developing. However, if these conventional measures fail, amputation may be required. Patients with Charcot foot arthropathy experienced 4.1 amputations per 100 persons. Compared with patients with Charcot alone, those with ulcer alone had seven times higher risk, and those with both an ulcer and Charcot had 12 times higher risk of amputation among patients older than 65. Approximately 40 percent of Charcot arthropathy patients have a concomitant ulceration.
Because of the serious consequences that Charcot foot can lead to, Regenative has sought to find an alternative solution so that amputation can be avoided. Regenative Labs has partnered with Dr. Michael Lavor to conduct a prospective study on the efficacy and safety of using Wharton’s jelly tissue allografts for Charcot foot. This study has been approved by the institutional review board of the Institute of Regenerative and Cellular Medicine.
THE CASE STUDY
In Regenative’s prospective study, the patient’s circumstances are uncommon but allow for the observation of Wharton’s jelly allograft serving multiple functions in one subject. The patient with known Charcot’s foot underwent surgery to investigate and remove a suspected infection. During the operation, no infection was found, but the synovium of the subtalar joint was severed and further macerated by the placement of a post-surgical wound vac. This left the patient with visible synovial fluid leakage and a 3.5cm deep wound down to the bone. The surgeon recommended immediate amputation.
After this recommendation, the patient contacted Dr. Lavor for emergency regenerative intervention to avoid amputation and improve the overall quality of life. Dr. Lavor began Wharton’s jelly applications and has seen immense improvement in wound depth, decreasing by 0.4cm, seven days after the first application, giving the patient hope. The study will continue until complete wound closure and will track overall patient progress with MRI, bone scans, and standard wound measuring.
“This patient had an open joint with a ruptured capsule. Wharton’s jelly was believed to decrease closure time and increase the healing process by stimulating granulation tissue growth around the opening. It provides a scaffolding that simulates the granulation tissue in the fascia and muscular tissue to close the wound. A total contact cast was used to stabilize the joint with an open window for dressing changes. Since the use of Wharton’s jelly, the synovial fluid has decreased by 60 percent to 70 percent, the number of dressing changes has reduced by 30 percent, and the wound has begun closing. The fascial opening has also narrowed in size and increased with granulation tissue,” said Dr. Lavor.
The results observed in this prospective case study may potentially lay the foundation for the use of Wharton’s jelly in other forms of lower limb wounds, such as diabetic foot ulcers, and in other Charcot patients with joint damage. The recording and publication of data in this prospective study may set a precedent for improving Charcot foot and its related wound care. Regenative Labs’ hope is that physicians can continue to improve patient care for Charcot foot patients with Wharton’s Jelly applications, thereby reducing the need for a life-altering surgery. Regenative Labs is excited for the future of patient care with the goal of increasing options for those who have Charcot foot.