References

Centers for Disease Control and Prevention. National diabetes statistics report. 2023. https://tinyurl.com/584ckuz4 (accessed 8 August 2024)

International Diabetes Federation. IDF Diabetes Atlas. 2021. https://diabetesatlas.org (accessed 27 August 2024)

Singh N, Armstrong DG, Lipsky BA Preventing foot ulcers in patients with diabetes. JAMA. 2005; 293:(2)217-228 https://doi.org/10.1001/jama.293.2.217

Alexiadou K, Doupis J Management of diabetic foot ulcers. Diabetes Ther. 2012; 3:(1) https://doi.org/10.1007/s13300-012-0004-9

Armstrong DG, Boulton AJ, Bus SA Diabetic foot ulcers and their recurrence. N Engl J Med. 2017; 376:(24)2367-2375 https://doi.org/10.1056/NEJMra1615439

Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA Healing diabetic neuropathic foot ulcers: are we getting better?. Diabet Med. 2005; 22:(2)172-176 https://doi.org/10.1111/j.1464-5491.2004.01375.x

Geiss LS, Li Y, Hora I Resurgence of diabetes-related nontraumatic lower-extremity amputation in the young and middle-aged adult U.S. population. Diabetes Care. 2019; 42:(1)50-54 https://doi.org/10.2337/dc18-1380

Edmonds M, Manu C, Vas P The current burden of diabetic foot disease. J Clin Orthop Trauma. 2021; 17:88-93 https://doi.org/10.1016/j.jcot.2021.01.017

Lepäntalo M, Apelqvist J, Setacci C Chapter V: Diabetic foot. Eur J Vasc Endovasc Surg. 2011; 42:S60-S74 https://doi.org/10.1016/S1078-5884(11)60012-9

Guo S, DiPietro LA Factors affecting wound healing. J Dent Res. 2010; 89:(3)219-229 https://doi.org/10.1177/0022034509359125

Schultz GS, Sibbald RG, Falanga V Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003; 11:S1-S28 https://doi.org/10.1046/j.1524-475X.11.s2.1.x

Margolis DJ, Kantor J, Berlin JA Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. Diabetes Care. 1999; 22:(5)692-695 https://doi.org/10.2337/diacare.22.5.692

Everett E, Mathioudakis N Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018; 1411:(1)153-165 https://doi.org/10.1111/nyas.13569

Aldana PC, Khachemoune A Diabetic foot ulcers: appraising standard of care and reviewing new trends in management. Am J Clin Dermatol. 2020; 21:(2)255-264 https://doi.org/10.1007/s40257-019-00495-x

Sheehan P, Jones P, Caselli A Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care. 2003; 26:(6)1879-1882 https://doi.org/10.2337/diacare.26.6.1879

Frykberg RG, Banks J Challenges in the treatment of chronic wounds. Adv Wound Care (New Rochelle). 2015; 4:(9)560-582 https://doi.org/10.1089/wound.2015.0635

Shah P, Inturi R, Anne D Wagner's classification as a tool for treating diabetic foot ulcers: our observations at a suburban teaching hospital. Cureus. 2022; 14:(1) https://doi.org/10.7759/cureus.21501

Schlottmann F, Bucan V, Vogt PM, Krezdorn N A short history of skin grafting in burns: from the gold standard of autologous skin grafting to the possibilities of allogeneic skin grafting with immunomodulatory approaches. Medicina (Kaunas). 2021; 57:(3) https://doi.org/10.3390/medicina57030225

Asuku M, Yu TC, Yan Q Split-thickness skin graft donor-site morbidity: a systematic literature review. Burns. 2021; 47:(7)1525-1546 https://doi.org/10.1016/j.burns.2021.02.014

Wu S, Carter M, Cole W Best practice for wound repair and regeneration use of cellular, acellular and matrix-like products (CAMPs). J Wound Care. 2023; 32:S1-S31 https://doi.org/10.12968/jowc.2023.32.Sup4b.S1

Costa A, Naranjo JD, Londono R, Badylak SF Biologic scaffolds. Cold Spring Harb Perspect Med. 2017; 7:(9) https://doi.org/10.1101/cshperspect.a025676

Badylak SF The extracellular matrix as a biologic scaffold material. Biomaterials. 2007; 28:(25)3587-3593 https://doi.org/10.1016/j.biomaterials.2007.04.043

Scarritt M, Murdock M, Badylak SF Chapter 35 – Biologic scaffolds composed of extracellular matrix for regenerative medicine, 3rd ed. In: Atala A, Lanza R, Mikos AG, Nerem R (eds). : Academic Press; 2019 https://doi.org/10.1016/B978-0-12-809880-6.00035-7

Turner NJ, Badylak SF The use of biologic scaffolds in the treatment of chronic nonhealing wounds. Adv Wound Care (New Rochelle). 2015; 4:(8)490-500 https://doi.org/10.1089/wound.2014.0604

Snyder D, Sullivan N, Margolis D, Schoelles K Appendix D: commercially available skin substitute products.: Agency for Healthcare Research and Quality; 2020

Reyzelman A, Crews RT, Moore JC Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study. Int Wound J. 2009; 6:(3)196-208 https://doi.org/10.1111/j.1742-481X.2009.00585.x

Walters J, Cazzell S, Pham H Healing rates in a multicenter assessment of a sterile, room temperature, acellular dermal matrix versus conventional care wound management and an active comparator in the treatment of full-thickness diabetic foot ulcers. Eplasty. 2016; 16

Cazzell S, Vayser D, Pham H A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017; 25:(3)483-497 https://doi.org/10.1111/wrr.12551

Reprise Biomedical, Inc. Miro3D Wound Matrix. https://reprisebio.com/miro3d/ (accessed 8 August 2024)

US Food & Drug Administration. 510(k) Premarket notification: K221520. 2022. https://tinyurl.com/ycjtn6ap (accessed 8 August 2024)

Crapo PM, Gilbert TW, Badylak SF An overview of tissue and whole organ decellularization processes. Biomaterials. 2011; 32:(12)3233-3243 https://doi.org/10.1016/j.biomaterials.2011.01.057

Ott HC, Matthiesen TS, Goh SK Perfusion-decellularized matrix: using nature's platform to engineer a bioartificial heart. Nat Med. 2008; 14:(2)213-221 https://doi.org/10.1038/nm1684

Taylor DA, Sampaio LC, Ferdous Z Decellularized matrices in regenerative medicine. Acta Biomater. 2018; 74:74-89 https://doi.org/10.1016/j.actbio.2018.04.044

Faulk DM, Wildemann JD, Badylak SF Decellularization and cell seeding of whole liver biologic scaffolds composed of extracellular matrix. J Clin Exp Hepatol. 2015; 5:(1)69-80 https://doi.org/10.1016/j.jceh.2014.03.043

A Mao S Sustained in vivo perfusion of a re-endothelialized tissue engineered porcine liver. International J Transplant Res Med. 2017; 3:(1)1-9 https://doi.org/10.23937/2572-4045.1510031

Uygun BE, Soto-Gutierrez A, Yagi H Organ reengineering through development of a transplantable recellularized liver graft using decellularized liver matrix. Nat Med. 2010; 16:(7)814-820 https://doi.org/10.1038/nm.2170

Seetapun D, Ross JJ Eliminating the organ transplant waiting list: The future with perfusion decellularized organs. Surgery. 2017; 161:(6)1474-1478 https://doi.org/10.1016/j.surg.2016.09.041

Reprise Biomedical, Inc. MiroDerm Biologic Wound Matrix. https://reprisebio.com/miroderm/ (accessed 8 August 2024)

Fridman R, Engelhardt J A pilot study to evaluate the effects of perfusion-decellularized porcine hepatic-derived wound matrix on difficult-to-heal diabetic foot ulcers. Wounds. 2017; 29:(10)317-323 https://doi.org/10.25270/WNDS/2017.10.317323

Fridman R, Rafat P, Van Gils CC Treatment of hard-to-heal diabetic foot ulcers with a hepatic-derived wound matrix. Wounds. 2020; 32:(9)244-252

Use of three-dimensional acellular collagen matrix in deep or tunnelling diabetic foot ulcers: a retrospective case series

02 September 2024
Volume 8 · Issue 2

Abstract

Objective:

While most xenograft wound matrices are flat sheets not designed for deep or tunnelling wounds, three-dimensional acellular collagen matrices (3D-ACM) can fill deep wound beds and enable full wound wall apposition. This case series examines the use of 3D-ACM in treating diabetic foot ulcers (DFUs) that are deep, tunnelling, undermining, or irregularly shaped. We report outcomes of cases where 3D-ACM was applied to deep or tunnelling DFUs present for at least four weeks.

Method:

In this retrospective case series, 3D-ACM was applied, healing was monitored and measurements were collected. Additional 3D-ACM was applied as needed.

Results:

In total, 11 patients with 13 wounds were treated. Improved wound appearance and reduced size were observed at most follow-ups. Mean initial wound depth was 1.6cm, and several wounds showed significant depth reductions shortly after therapy initiation. In total, 62% of wounds (8/13) reached 50% closure by four weeks. Additionally, 54% (7/13) were fully closed by 12 weeks. The remaining 46% (6/13) took between 12–22.3 weeks to heal. Overall mean therapy time was 13.1 weeks (range: 2.0–22.3 weeks). Deeper wounds generally took longer to close.

Conclusion:

The findings of this case series showed that 3D-ACM could offer a protective microenvironment for wound management for deep or tunnelling DFUs. While some took >12 weeks to close, this may be attributable to large initial depths and volumes, rather than a failure to respond to the treatment modality. Other wounds that require a conforming 3D matrix, enabling full wound wall apposition, may benefit from 3D-ACM. Further investigations would be beneficial to understand the capabilities of thistreatment modality.

An estimated 38.4 million people in the US live with diabetes, constituting 11.6% of the population.1 Globally, as of 2021, the number of adults with diabetes has been estimated at 537 million.2 Among the diabetic population, the prevalence of diabetic foot ulcers (DFUs) ranges from 4–10%, with the lifetime risk of developing a DFU ranging from 15–25%.3,4 Moreover, according to a 2017 study, the annual incidence of DFUs worldwide ranged from 9.1–26.1 million.5

DFUs are a major source of morbidity for patients with diabetes and can impose considerable physical, psychological and financial burdens.6,7 DFUs are often associated with peripheral neuropathy and peripheral arterial disease of the lower limb. Reduced blood flow and lack of sensation in the lower limb mean that many DFUs worsen or become infected without the patient noticing. Roughly 50–60% of DFUs develop infections; of those, 20% result in lower extremity amputations.8 It is estimated that 85% of all amputations involving patients with diabetes are preceded by a hard-to-heal (chronic) DFU that has deteriorated to a severe infection or gangrene.9

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