References

Carter MJ, DaVanzo J, Haught R Chronic wound prevalence and the associated cost of treatment in Medicare beneficiaries: changes between 2014 and 2019. J Med Econ. 2023; 26:(1)894-901 https://doi.org/10.1080/13696998.2023.2232256

Hirpa D, Bekela T, Abdissa D Prevalence of diabetic foot ulcer and its associated factors among diabetes patients on follow up at public hospitals in West Shewa Zone, Oromia, Ethiopia. Int J Afr Nurs Sci. 2023; 19 https://doi.org/10.1016/j.ijans.2023.100578

Armstrong DG, Swerdlow MA, Armstrong AA Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020; 13:(1) https://doi.org/10.1186/s13047-020-00383-2

Hicks CW, Selvarajah S, Mathioudakis N Burden of infected diabetic foot ulcers on hospital admissions and costs. Ann Vasc Surg. 2016; 33:149-158 https://doi.org/10.1016/j.avsg.2015.11.025

Fife CE, Eckert KA, Carter MJ Publicly reported wound healing rates: The fantasy and the reality. Adv Wound Care. 2018; 7:(3)77-94 https://doi.org/10.1089/wound.2017.0743

Raja JM, Maturana MA, Kayali S Diabetic foot ulcer: a comprehensive review of pathophysiology and management modalities. World J Clin Cases. 2023; 11:(8)1684-1693 https://doi.org/10.12998/wjcc.v11.i8.1684

Snyder RJ, Schultz G, Wachuku C Proposed mechanism of action of topically applied autologous blood clot tissue. J Am Podiatr Med Assoc. 2023; 113:(3)20-140 https://doi.org/10.7547/20-140

McDermott K, Fang M, Boulton AJ Etiology, epidemiology, and disparities in the burden of diabetic foot ulcers. Diabetes Care. 2023; 46:(1)209-221 https://doi.org/10.2337/dci22-0043

Kushnir I, Kushnir A, Serena TE, Garfinkel D Efficacy and safety of a novel autologous wound matrix in the management of complicated, chronic wounds: a pilot study. Wounds. 2016; 28:(9)317-327

Snyder RJ, Kasper MA, Patel K Safety and efficacy of an autologous blood clot product in the management of Texas 1A or 2A neuropathic diabetic foot ulcers: a prospective, multicenter, open label pilot study. Wounds. 2018; 30:(7)84-89

Williams M, Davidson D, Wahab N Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers. Wounds. 2022; 34:(7)195-200 https://doi.org/10.25270/wnds/21089

Landau Z, Whitacre KL, Leewood C Utilization of a topical autologous blood clot for treatment of pressure ulcers. Int Wound J. 2023; 20:(3)806-812 https://doi.org/10.1111/iwj.13927

Gurevich M, Heinz SM, Fridman R Use of autologous whole blood clot in the treatment of complex surgical wounds: a case series. J Wound Care. 2023; 32:S4-S9 https://doi.org/10.12968/jowc.2023.32.Sup2.S4

An observational pilot study to collect safety and efficacy data on wound care using whole blood clot technology on hard-to-heal wounds. 2021. https://tinyurl.com/3mfj5c6a (accessed 6 August 2024)

Gurevich M, Wahab N, Wachuku C ActiGraft treatment in complex wounds with exposed structure: a case series. Ann Rev Resear. 2021; 7:(1) https://doi.org/10.19080/ARR.2021.07.555701

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

U.S. Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE) version 5.0. 2017. https://tinyurl.com/y8cemctr (accessed 12 August 2024)

Erratum. Wound Repair Regen. 2019; 27:(4)435-435 https://doi.org/10.1111/wrr.12725

van Dorn A COVID-19 and readjusting clinical trials. Lancet. 2020; 396:(10250)523-524 https://doi.org/10.1016/S0140-6736(20)31787-6

Audisio K, Lia H, Robinson N Impact of the COVID-19 pandemic on non-COVID-19 clinical trials. J Cardiovasc Dev Dis. 2022; 9:(1) https://doi.org/10.3390/jcdd9010019

Al-Jalodi O, Kupcella M, Breisinger K, Serena TE A multicenter clinical trial evaluating the durability of diabetic foot ulcer healing in ulcers treated with topical oxygen and standard of care versus standard of care alone 1 year post healing. Int Wound J. 2022; 19:(7)1838-1842 https://doi.org/10.1111/iwj.13789

Snyder R, Driver V, Cole W Topical autologous blood clot therapy: an introduction and development of consensus panel to guide use in the treatment of complex wound types. Wounds. 2022; 34:(9)223-228 https://doi.org/10.25270/wnds/22011

Snyder RJ, Lantis J, Kirsner RS Macrophages: a review of their role in wound healing and their therapeutic use. Wound Repair Regen. 2016; 24:(4)613-629 https://doi.org/10.1111/wrr.12444

Hard-to-heal wounds

Wound dressings

Clinical/pre-clinical research

Efficacy and safety of autologous whole blood clot in diabetic foot ulcers: a randomised controlled trial

02 September 2024

Research

02 September 2024

Volume 8 · Issue 2

ISSN (online): 2514-2585

Digital Issue

Abstract

Objective:

Diabetic foot ulcers (DFUs) present a significant global health challenge, resulting in high morbidity and economic costs. Current available treatments often fail to achieve satisfactory healing rates, highlighting the need for novel therapies. This study evaluated the safety and efficacy of a novel autologous whole blood clot (AWBC)—a blood-based, biodegradable provisional matrix—in conjunction with standard of care (SoC) when compared to SoC alone in the treatment of hard-to-heal DFUs.

Method:

A multicentre, prospective, blinded assessor, randomised controlled trial was conducted at 16 sites across the US, South Africa and Turkey. A cohort of patients with hard-to-heal DFUs was enrolled and randomised to either the AWBC group or the control group. The primary endpoint was complete wound closure at 12 weeks, while secondary endpoints included time to heal and percentage area reduction (PAR) at four and eight weeks. Data were analysed using both intention-to-treat (ITT) and per-protocol (PP) populations.

Results:

The cohort included 119 patients. AWBC treatment resulted in a significantly higher healing rate compared to the control in both ITT (41% versus 15%, respectively; p=0.002) and PP populations (51% versus 18%, respectively; p=0.0075). AWBC treatment also resulted in a shorter mean time to heal and higher durability of wound closure. Safety analysis showed a similar incidence of adverse events (AEs) between groups, with no device-related AEs.

Conclusion:

The AWBC system, by modulating the wound microenvironment and providing a functional extracellular matrix, offered a promising new approach to treating hard-to-heal DFUs, demonstrating superior healing outcomes compared to SoC alone in this study.

Globally, diabetic foot ulcers (DFUs) pose a significant social and economic burden, with Medicare incurring nearly $4 billion USD in DFU-related costs in 2019.¹ Despite many advances made in the management of diabetes, complications related to DFUs remain a global public health issue. The mortality rate among patients with a DFU is two-times greater compared to patients with diabetes who do not present with a DFU.² Cases of DFU account for the highest rate of non-traumatic lower extremity amputations, with a five-year mortality rate of 30%.^3,4 Among real-world patients in the US Wound Registry, only 30% of those who presented with a DFU healed at 12 weeks.⁵ Despite advances in wound management options for DFUs, safe and effective novel treatment options for hard-to-heal DFUs are urgently needed to improve wound healing outcomes.

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