A Small WIN: A Case Review on Amniotic Grafting for Wound Healing Volume 56- Issue 2

Chinmay Chauhan^1,2*, Fadi Z Jaafar³ and Alex C Spinoso⁴

• ¹Managing Member at Siddhey LLC Healthcare Consulting
• ²NCT06328010 – Clinicaltrials.gov
• ⁵Podiatrist with Precision Foot & Ankle Institute, affiliated with medical facilities such as MyMichigan Medical Center Alpena and McLaren Central Michigan
• ⁶Seasoned family medicine practitioner, Medical School: St. George’s University School of Medicine Residency in Family Medicine: Eisenhower Medical Center

Received: March 12, 2024; Published: April 18, 2024

*Corresponding author: Chinmay Chauhan, Managing Member at Siddhey LLC Healthcare Consulting, NCT06328010 – Clinicaltrials.gov, 215 E Warm Springs Rd, Suite 107-108, Las Vegas, NV 89119.

DOI: 10.26717/BJSTR.2024.56.008819

Abstract PDF

Abbreviations: SOC: Standard of Care; TL HAMA: Triple Layer Human Amniotic Membrane Allograft; TL: Triple Layer; RCTs: Randomized Controlled Trials; VLUs: Venous Leg Ulcers; dHACA: Dehydrated Human Amnion/Chorion Allografts

Wound healing is a complex process influenced by various factors, including patient-specific conditions and wound etiology. Chronic wounds, such as diabetic foot ulcers, venous leg ulcers, and post-MOHS surgery wounds, pose significant challenges to patients’ quality of life and healthcare systems. In recent years, amniotic grafts have emerged as a promising therapeutic option due to their unique properties and potential to enhance wound healing.

The human amniotic membrane, derived from the placenta, possesses several remarkable qualities that make it an attractive wound healing material. These include:

1) Rich Milieu of Bioactive Factors: The amniotic membrane contains amino acids, growth factors, and other nutrients essential for tissue repair. These components facilitate its intrauterine function and contribute to its healing properties [1].

2) Cell Migration and Repair: Human Amniotic Allograft Membrane (HAMA) supports wound healing by promoting cell migration and tissue repair. It acts as a scaffold, facilitating the regeneration of damaged tissues [1].

3) The Acesso Biologics product line encompasses single-layer, double-layer, and triple-layer allografts. These allografts consist of dehydrated, terminally irradiated membranes and are available in various configurations and sizes, catering to diverse physician preferences. Notably, the product line includes NeoStim TL (Triple Layer)

4) In this specific utilization case study, the triple-layer HAMA (regulated under Section 361 of the Public Health Service Act) was employed. This particular allograft is intended for homologous use.

Diabetic foot ulcers are a common complication in individuals with diabetes. HAMA has been studied extensively in this context. Here are key findings:

• Clinical Studies: Randomized controlled trials (RCTs) and observational studies have evaluated HAMA’s effectiveness in diabetic foot ulcer treatment. Most RCTs reported significantly higher wound closure rates compared to conventional treatments. Additionally, large chronic ulcers resistant to standard therapy achieved closure with amniotic membrane allografts [1].

• Reduction in Healing Time: Despite study heterogeneity, current evidence suggests that amniotic membrane allografts reduce healing time compared to conventional methods [1].

Venous leg ulcers (VLUs) are a common manifestation of venous insufficiency. Recent clinical data highlights the efficacy of dehydrated human amnion/chorion allografts (dHACA) in treating diabetic wounds. These grafts contain endogenous growth factors that facilitate wound healing. In a prospective, multi-center trial, dHACA demonstrated superior healing rates compared to other bioengineered skin substitutes [2,3].

MOHS surgery, commonly used for skin cancer removal, often leaves sizable wounds. Amniotic grafts have shown promise in this context:

• Wound Closure: Studies employing different preparation methods of amniotic membranes have reported successful wound closure in MOHS surgery patients. The unique properties of HAMA contribute to tissue regeneration and expedited healing [1].

Amniotic grafting represents a valuable addition to wound healing strategies. While further research is needed to standardize protocols and assess long-term outcomes, current evidence supports its use in diabetic foot ulcers, venous insufficiency, and MOHS surgery treatment. Clinicians should consider individual patient factors and tailor treatment plans accordingly. In summary, the amniotic membrane’s regenerative potential holds great promise for improving wound healing outcomes across diverse patient populations.

55-year-old diabetic patient with primary complain of ulcer on the right foot. Past medical history includes diabetes and high blood pressure. For appropriation of this comparison we are reviewing the treatment of two Right Foot DFU on the same patient; first wound treated with standard of care and the second wound treated with a triple layer allograft from Acesso Biologics a human amniotic membrane allograft (HAMA) (Figures 1-3) (Tables 1 & 2).

Figure 1

Figure 2

Figure 3

Table 1:

Table 2:

Note: **Pt feels “good” and not available for follow up.

In this study, we compared conservative treatment with the established standard of care (SOC) for both wounds. Our focus was on treatment efficacy and patient response, particularly considering the psychosocial aspects. For wound #1, during the period from Week 15 to Week 22 (8 weeks of SOC therapy), there were no missed events, and wound closure was achieved. This was in contrast to the initial 6 weeks (Week 1 to Week 6), which involved two consecutive weeks of advanced treatment followed by one SOC session to achieve closure. Since both wounds were located on the patient’s right foot and successfully closed, we must also consider the patient’s overall well-being. Notably, the patient healed in half the time when comparing SOC to TL HAMA treatment. Despite multiple breaks in treatment, wound closure was still achieved. In modern medicine, recognizing the importance of a “happy patient” as a crucial component of health management is essential. If HAMA treatments can be more actively utilized, we can anticipate shorter therapy durations and, most importantly, improved patient satisfaction. However, further research is necessary to validate these healing rates and document any psychosocial changes resulting from expedited treatment methodologies. As poet Amanda Gorman aptly puts it, “We are moving in the right direction.”

1. Lakmal K, Basnayake O, Hettiarachchi D (2021) Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment. BMC Surgery 21(1): 87.
2. Amniotic fluid-derived multipotent stromal cells drive diabetic wound healing. Journal of Translational Medicine 18(1): 63.
3. Amniotic membrane wound grafts improve healing rates for venous leg ulcers. Venous News.