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Case ReportOpen Access

Successful Use of Amniotic Graft in Healing a Chronic Ulcer Aggravated by Peripheral Vascular Disease (PVD) Volume 63- Issue 4

Chinmay Chauhan1*, Julie Schottenstein2 M.S., D.P.M, F.A.C.F.A.S, F.A.C.P.M, C.I.M.E, Sanford Barsky3 MD, Andrei Razsadin4 DC, Tejal M Patel2 RN MSN CCRN, Matthew Raju Indukuri5

  • 1Managing Member, Siddhey LLC Healthcare Consulting
  • 2Collaborator
  • 3Department of Pathology, Anatomy and Cell Biology and the Clinical and Translational Research Center of Excellence, Meharry Medical College, 1005 Dr DB Todd Jr Blvd, Nashville, TN 37208
  • 4ABIME, QME, Doctor of Chiropractic Cleveland University Los Angeles, Functional Medicine Hyperbaric Practitioner, CA
  • 5Research Assistant

Received: October 18, 2025; Published: October 29, 2025

*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, USA.
Deputy Editor: Ana Catherine V. Madrid RM RN

DOI: 10.26717/BJSTR.2025.63.009934

Abstract PDF

ABSTRACT

Chronic wounds in patients with peripheral vascular disease (PVD) present significant challenges due to impaired perfusion, delayed healing, and increased risk of infection. This case study documents the successful use of XCELL AmnioMatrix™ (XAM), a lyophilized amniotic allograft, in closing a hard-to-heal ulcer that had plateaued under standard of care (SOC). The patient was enrolled in an independent open-label clinical registry (NCT06328010) benchmarking healing and closure rates of cellular, acellular, and matrix-like amniotic grafts. Transitioning from SOC to XAM therapy resulted in accelerated wound closure and complete epithelialization within 15 weeks, demonstrating the clinical utility of amniotic grafts in complex vascular-related wounds.

Abbreviations: PVD: Peripheral Vascular Disease; XAM: XCELL Amnio Matrix; SOC: Standard of Care; VLUs: Venous Leg Ulcers; CAMPS: Cellular, Acellular, and Matrix-Like Products

Introduction

Chronic wounds, particularly venous leg ulcers (VLUs) and ulcers complicated by PVD, are notoriously resistant to healing. Standard of care—including debridement, infection control, and compression— often yields limited progress in patients with vascular compromise. Amniotic membrane grafts, classified under cellular, acellular, and matrix-like products (CAMPS), have emerged as advanced biologic therapies. Their unique properties include:

• Reservoir of bioactive molecules: growth factors, cytokines, and amino acids that promote repair.

• Biologic scaffold: supports cell migration and tissue regeneration.

• Barrier and moisture retention: protects against infection while maintaining an optimal wound environment.

• Product versatility: XCELL AmnioMatrix™ is a terminally sterilized, lyophilized single-layer amniotic membrane that is easy to handle, requires no rehydration, and provides a natural extracellular matrix scaffold. This case highlights the clinical success of XAM in a patient with PVD, where SOC alone was insufficient to achieve wound closure.

Case Presentation Registry cited NCT06328010 (ClinicalTrials.gov)

Patient Profile

• 81-year-old male

• History: PVD, hypertension, chronic anticoagulation (Eliquis 5 mg BID)

• Injury: Traumatic degloving wound of the right lateral leg following a fall

• Complication: Wound dehiscence within one week, evolving into a chronic ulcer

Initial Management

• Serial sharp debridements

• MSSA infection treated with doxycycline followed by Augmentin

• Adequate vascular status confirmed

• After 4 weeks of SOC, <50% improvement was observed → wound reclassified as venous ulcer secondary to PVD

Advanced Therapy

• XAM grafting initiated at week 7

• Patient demonstrated excellent compliance with dressing care, elevation, and follow-up Figures (1,2,3,4 & 5).

Figure 1

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Figure 2

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Figure 3

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Figure 4

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Figure 5

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Results

(Table 1)

Table 1: CT Exam Protocol.

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Key Observations

• SOC (weeks 1–6): modest reduction in wound size, plateau in healing

• XAM therapy (weeks 7–15): rapid and consistent reduction in wound area and volume

• Complete epithelialization achieved by week 15

Discussion

This case underscores the clinical value of amniotic grafts in managing chronic wounds complicated by vascular disease. The biologic activity of XAM likely contributed to:

• Enhanced cellular migration and angiogenesis
• Reduction in wound depth and volume
• Accelerated closure compared to SOC alone

The patient’s enrollment in the open-label registry (NCT06328010) provided structured data capture, reinforcing the reproducibility of these results in real-world settings [1-5].

Conclusion

The transition from SOC to XCELL AmnioMatrix™ was pivotal in achieving wound closure in this PVD-complicated ulcer. This case demonstrates that amniotic grafts can convert stalled healing trajectories into successful outcomes. As registry data accumulates, XAM and similar amniotic products may establish themselves as standard adjunctive therapies for chronic wounds resistant to conventional care.

References

  1. Sabbatini M, Boffano P, Ferrillo M, Mario Migliario, Filippo Reno (2023) The Human Amniotic Membrane: A Rediscovered Tool to Improve Wound Healing in Oral Surgery. Int J Mol Sci 26(17): 8470.
  2. Elkhenany H, El Derby A, Abd Elkodous M, Radwa A Salah, Ahmed Lotfy, et al. (2022) Applications of the Amniotic Membrane in Tissue Engineering and Regeneration. Stem Cell Res Ther 13(1): 8.
  3. Swezey L (2015) What Amniotic Membrane Is and How It Is Used in Wound Care. Wound Source.
  4. Precise Bioscience. Xcell Amnio Matrix Product Insert.
  5. Mosti G, Atkin L, et al. Leg Ulceration in Venous and Arteriovenous Insufficiency: Assessment and Management with Compression Therapy. J Wound Care.