Amniotic membranes have been used for over 100 years as a biological dressing for various applications. This includes both traumatic and non-traumatic wounds.

FloGraft® is a product from Applied Biologics which is a human allograft derived from prescreened, live donors during C-section procedure. The donors are all screened medically and educated on the type of tissue harvested, which include amniotic cells only. The tissue is comprised of chorion-free amnion and amniotic fluid. The tissue is aseptically recovered and cryopreserved for clinical use as a soft tissue defect filler. The chorion layer is removed to help reduce a possible immune response from donor to host.

FloGraft® is a liquid allograft which is processed to preserve the structural qualities of the amniotic membrane and fluid is implanted into a soft tissue defect with 22 or 23 gauge needles. The amniotic fluid contains growth factors, amnion epithelial cells and amnion mesenchymal stromal cells, collagen type I, II, III, V and VI, Interleukin 10 (IL-10) and numerous other bacteriocidal components. The membrane also contains proteins, carbohydrates, lipids, peptides, epidermal growth factors, transforming growth factor (TGF)-a, TGF-b1, and Fibroblast growth factors (FGF). The FloGraft® also contains hyaluronic acid, cytokines and native organic nutrients.The amniotic fluid contains nutrients and growth factors which are responsible for anti-inflammatory, anti -adhesive and anti-microbial properties.

FloGraft® is indicated as a tissue void filler and has a broad applicability to numerous indications, including: Achilles tendinitis and tendinosis, plantar fasciitis and fasciosis, Haglund’s deformity, cheilectomy, chronic non-healing wounds, non-unions, complex fractures, tendon repair, nerve repair, ligament repair, Charcot foot, epicondylitis, post-operative inflammation, carpal tunnel, facet-based pain.

Case Report

A 61-year-old male had chronic pain in the right heel with difficulty walking or standing. He is a mail carrier and could not perform the activity that his work required He was treated conservatively for two months with ice, compression physical therapy and a cam walker boot. He did not improve significantly and developed marked edema and thickening of his Achilles tendon. His pain was localized to the posterior heel. There was pain on dorsiflexion with and without activity.

His medical history included a history of varicosities and lymphedema of both legs.

A general physical exam revealed no weight change, generally healthy, no change in strength or exercise tolerance. A musculoskeletal exam revealed no pain in the joints, no limitation of range of motion, no paresthesias or numbness except pain in the right heel. There was good muscle strength in all muscle groups of the lower extremities bilateral. There was mild equinus on the right as compared to the left foot and ankle. A neurologic exam revealed no weakness, no tremor, no seizures, no changes in mentation, no ataxia. Significant findings included swelling and thickness of the right Achilles tendon, along with pain upon dorsiflexion/plantarflexion of the ankle. X-rays showed a posterior and larger plantar heel spur with soft tissue swelling of the posterior heel.

A diagnosis of enthesopathy of the Achilles tendon without compete tear but with interstitial tearing within the substance of the Achilles tendon was established, with a history of failed conservative therapy.

Treatment consisted of tenolysis with the application of a singe FloGraft® 0.5cc (diluted to 2.0ccs total volume using 1.5ccs of plain lidocaine) into the tendon at its most inflamed area. The patient was immobilized in a jones compression type dressing for one week.

Before Treatment

After Treatment

On follow-up at one week post application of FloGraft®, patient had a significant reduction in pain and swelling.

On follow-up at three weeks post application of FloGraft®, patient had no pain, no swelling and was able to return back to work without restrictions. His pain and swelling resolved completely. At four months post application, he had no return of symptoms.

In conclusion, FloGraft® is a powerful biological allograft, derived from human amnion and amniotic fluid, which is a potent anti-inflammatory, anti-adhesive, anti-infective fluid, which increases healing by sending a signal to recruit healthy cells to migrate to unhealthy damaged tissue and promotes rapid healing within the tissues. When applied to the treatment of enthesopathy of the Achilles tendon, it is an excellent alternative to surgical repair of the thickened, fibrotic Achilles tendon and is effective in eliminating the resultant recalcitrant heel pain.

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Amniotic Membrane & Fluid: A Biologic System FloGraft® is human allograft derived from prescreened, live, healthy donors comprised of chorion-free amnion and amniotic fluid. The tissue is aseptically recovered, processed and cryopreserved to provide well-preserved human tissue for clinical use as a soft-tissue defect filler. Amniotic membrane and fluid act as a biologic system that ensures symmetrical structure development and growth; cushions and protects the embryo; has a significant defensive role as a part of the innate immune system, and protects the fetus by maintaining consistent pressure and temperature. As a liquid allograft, FloGraft® retains this protective function by acting as a tissue matrix for use in filling soft tissue defects, or for points of localized inflammation.

To learn more about Applied Biologics FlōGraft®, and its products and services, please contact us.