Neurotrophic Keratitis with Ocular Surface Damage and Inflammation That Does Not Respond to Conservative Therapy

For individuals who have neurotrophic keratitis with ocular surface damage and inflammation that does
not respond to conservative therapy who receive HAM, the evidence includes an RCT. Relevant outcome
are symptoms, morbid events, functional outcomes, and quality of life. An RCT of 30 patients showed no
benefit of sutured HAM graft compared to tarsorrhaphy or bandage contact lens. Based on clinical input,
HAM might be considered for patients who did not respond to conservative therapy. Clinical input
indicated that non-sutured HAM in an office setting would be preferred to avoid a delay in treatment
associated with scheduling a surgical treatment. The evidence is sufficient to determine that the
technology results in a meaningful improvement in the net health outcome.

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Plantar Fasciitis


The evidence on injection of amniotic membrane for the treatment of plantar fasciitis includes preliminary
studies and a larger (n=145) patient-blinded comparison of micronized injectable-HAM and placebo
control. Injection of micronized amniotic membrane resulted in greater improvements in the visual analog
score for pain and the Foot Functional Index compared to placebo controls. The primary limitation of the
study is that this is an interim report with 12-month results pending. The evidence is insufficient to
determine the effects of the technology on health outcomes.

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Osteoarthritis

For individuals who have knee osteoarthritis who receive an injection of suspension or particulate
formulation of HAM or amniotic fluid, the evidence includes a feasibility study. Relevant outcomes are
symptoms, functional outcomes, quality of life, and treatment-related morbidity. The pilot study assessed
the feasibility of a larger RCT evaluating HAM injection. Additional trials, which will have a larger sample
size and longer follow-up, are needed to permit conclusions on the effect of this treatment. The evidence
is insufficient to determine the effects of the technology on health outcomes.

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Lower-Extremity Ulcers due to Venous Insufficiency

For individuals who have lower-extremity ulcers due to venous insufficiency who receive a patch or
flowable formulation of HAM, the evidence includes 2 RCTs. Relevant outcomes are symptoms, morbid
events, functional outcomes, and quality of life. The published evidence on HAM for the treatment of
venous leg ulcers includes 2 multicenter RCTs with EpiFix. One RCT reported a larger percent wound
closure at 4 weeks, but the percentage of patients with complete wound closure at 4 weeks did not differ
between EpiFix and the standard of care. A second RCT evaluated complete wound closure at 12 weeks
after weekly application of EpiFix or standard dressings with compression, but interpretation is limited by
methodologic concerns. Two additional studies with other HAM products have been completed but not
published, raising further questions about the efficacy of HAM for venous insufficiency ulcers. Therefore,
corroboration with well-designed and well-conducted RCTs evaluating wound healing is needed to
demonstrate efficacy for this indication. The evidence is insufficient to determine the effects of the
technology on health outcomes.

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Diabetic Lower-Extremity Ulcers

Diabetic Lower-Extremity Ulcers For individuals who have non-healing diabetic lower-extremity ulcers who receive a patch or flowable formulation of HAM or placental membrane (ie, AmnioBand Membrane, AmnioExcel, Biovance, EpiCord, EpiFix, Grafix), the evidence includes randomized controlled trials (RCTs). Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. The RCTs evaluating amniotic and placental membrane products for the treatment of non-healing (<20% healing with ≥2 weeks of standard 12 care) diabetic lower-extremity ulcers have compared HAM with standard care or with an established advanced wound care product. These trials used wound closure as the primary outcome measure, and some used power analysis, blinded assessment of wound healing, and intention-to-treat analysis. For the HAM products that have been sufficiently evaluated (ie, AmnioBand Membrane, Biovance, EpiCord, EpiFix, Grafix), results have shown improved outcomes compared with standard care, and outcomes that are at least as good as an established advanced wound care product. Improved health outcomes in the RCTs are supported by multicenter registries. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

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