Peer-Reviewed Articles

A curated, filterable collection of peer-reviewed journal articles, meta-analyses, and clinical studies supporting amniotic allografts and autologous blood clots.

A Multicenter, Prospective, Randomized, Controlled, Trial, Comparing the Safety and Efficacy of Autologous Whole Blood Clot to Standard of Care in Patients with Chronic Diabetic Foot Ulcers

A Multicenter, Prospective, Randomized, Controlled, Trial, Comparing the Safety and Efficacy of Autologous Whole Blood Clot to Standard of Care in Patients with Chronic Diabetic Foot Ulcers

https://doi.org/10.12968/jowc.2024.0195

Study: Diabetic foot ulcers (DFUs) present a significant global health challenge, resulting in high morbidity and economic costs. Current treatments often fail to achieve satisfactory healing rates, highlighting the need for novel therapies. This study evaluates the safety and efficacy of a novel autologous whole blood clot (AWBC), a blood-based, biodegradable... more
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

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

https://pubmed.ncbi.nlm.nih.gov/28544150/

Study: This multicenter, prospective, randomized controlled trial enrolled 168 chronic diabetic foot ulcer (DFU) subjects across 13 centers in 9 U.S. states to compare a thoroughly decellularized, room-temperature, sterile human acellular dermal matrix (D-ADM / DermACELL) against conventional care and an active ADM comparator (GJ-ADM / GraftJacket). Subjects were followed for... more
ActiGraft Topically Applied Blood Clot Therapy

ActiGraft Topically Applied Blood Clot Therapy

https://podiatrym.com/Clinical_Innovations2.cfm?id=2807

Study: ActiGraft is a topically applied blood clot therapy supported by evidence of efficacy in treating foot ucler patients with diabetes. There are 34.2 million patients with diabetes in the United States with foot ulcers considered one of the most common complications of diabetes. Complex ulcerations with exposed tendon and bone... more
ActiGraft Treatment In Complex Wounds With Exposed Structure – A Case Series

ActiGraft Treatment In Complex Wounds With Exposed Structure – A Case Series

https://juniperpublishers.com/arr/pdf/ARR.MS.ID.555701.pdf

Study: Limb amputations as a result of non-healing complex wounds continues to be with high prevalence. A non-healing wound can deteriorate and have an extensive breakdown of soft tissue that may cause exposure of vital structures. In complex wounds with exposed structures, ActiGraft proved to: Achieve coverage of these vital structures... more
Amnion Membrane in Diabetic Foot Wounds: A Meta-analysis

Amnion Membrane in Diabetic Foot Wounds: A Meta-analysis

https://pmc.ncbi.nlm.nih.gov/articles/PMC5426882/

Study: Amniotic membrane is tissue obtained from human placenta rich in cytokines, growth factors, and stem cells that possess the ability to inhibit infection, improve healing, and stimulate regeneration. A meta-analysis was performed examining randomized controlled trials comparing amniotic tissue products with standard of care in nonhealing diabetic foot ulcers, including... more
Amniotic Membrane Transplantation for Wound Healing, Tissue Regeneration and Immune Modulation

Amniotic Membrane Transplantation for Wound Healing, Tissue Regeneration and Immune Modulation

https://pmc.ncbi.nlm.nih.gov/articles/PMC12316762/

Study: Amniotic membrane transplantation (AMT) has emerged as a versatile therapeutic modality with significant applications in wound healing, tissue regeneration, and ophthalmology. This comprehensive review evaluates AMT’s efficacy in acute and chronic wound management, where it has been shown to alleviate pain, reduce infection risk, and facilitate epithelialization. In chronic wounds,... more
Amniotic Membrane: New Concepts for an Old Dressing

Amniotic Membrane: New Concepts for an Old Dressing

https://pubmed.ncbi.nlm.nih.gov/25041617/

Study: The amniotic membrane is the innermost layer of fetal membranes that surrounds and protects the embryo. Amniotic epithelial cells are a rich source of biologically active factors known to promote cell proliferation and differentiation, making the amniotic membrane an attractive wound dressing material. Despite a large number of publications reporting... more
An Evaluation of Dehydrated Human Amniotic Membrane Allografts in Patients with DFUs

An Evaluation of Dehydrated Human Amniotic Membrane Allografts in Patients with DFUs

https://pubmed.ncbi.nlm.nih.gov/24159656/

Study: This study evaluates healing of chronic diabetic foot ulcers (DFUs) with use of dehydrated human amniotic membrane (dHAM) in patients failing under standard of care treatment. Eleven patients were included in the study. Mean wound chronicity was 21.1 ± 12.4 weeks and mean wound size was 4.7 ± 5.0 cm²... more
An Observational Pilot Study To Collect Safety And Efficacy Data On Wound Care Using Whole Blood Clot Technology On Hard-To-Heal Wounds

An Observational Pilot Study To Collect Safety And Efficacy Data On Wound Care Using Whole Blood Clot Technology On Hard-To-Heal Wounds

https://woundsinternational.com/journal-articles/observational-pilot-study-collect-safety-and-efficacy-data-wound-care-using-whole-blood-clot-technology-hard-heal-wounds/

Study: The observational pilot study demonstrates the safety and efficacy for whole blood clot (WBC) technology in a wide variety of hard-to-heal wounds. An average of 65% reduction in patients’ wound size was achieved by week 4 and 94% by week 12. In 4 of the cases described, not only did... more
Chronic Venous Ulcer Pain Reduction And Full Recovery By An Autologous Blood Clot: A Case Study

Chronic Venous Ulcer Pain Reduction And Full Recovery By An Autologous Blood Clot: A Case Study

www.doi.org/10.52768/2766-7820/1714

Study: Venous leg ulcers (VLUs) can be associated with severe pain, having a tremendous effect on the ulcer treatment and eventually the patient’s life. While background pain is common in chronic wounds, dressing removal and procedures are the main cause for VLU pain. This case study features a 63-year-old patient with... more
Efficacy And Safety of A Novel Autologous Wound Matrix In The Management of Complicated, Chronic Wounds: A Pilot Study

Efficacy And Safety of A Novel Autologous Wound Matrix In The Management of Complicated, Chronic Wounds: A Pilot Study

https://pubmed.ncbi.nlm.nih.gov/27701127/

Study: The objective of this pilot study was to evaluate the efficacy and safety of a novel method using an autologous whole blood clot formed with the RedDress Wound Care System (RD1, RedDress Ltd, Israel), a provisional whole blood clot matrix used in the treatment of chronic wounds of various etiologies.... more
Efficacy and Safety of Acellular Dermal Matrix in Diabetic Foot Ulcer Treatment: A Systematic Review and Meta-Analysis

Efficacy and Safety of Acellular Dermal Matrix in Diabetic Foot Ulcer Treatment: A Systematic Review and Meta-Analysis

https://pubmed.ncbi.nlm.nih.gov/28232031/

Study: Diabetic foot ulcer (DFU) is a chronic, refractory disease requiring multidisciplinary management. Acellular dermal matrix (ADM) has emerged as a promising intervention, but its efficacy and safety had remained controversial at the time of this publication. The authors searched PubMed, Medline, Embase, and the Cochrane Library to identify randomized controlled... more
Extracellular Matrix Biomaterials for Soft Tissue Repair

Extracellular Matrix Biomaterials for Soft Tissue Repair

https://pubmed.ncbi.nlm.nih.gov/19778685/

Study: Extracellular matrix (ECM)-derived implants continue to challenge and refine the conventional wisdom of biomaterials in soft tissue repair. This review recognizes that different tissue-processing methodologies produce ECM devices with characteristic post-implantation responses. These range from classic foreign body encapsulation of a permanent implant, to biodegradation and resorption, to a response... more
Financial Burden of Diabetic Foot Ulcers to World: A Progressive Topic to Discuss Always

Financial Burden of Diabetic Foot Ulcers to World: A Progressive Topic to Discuss Always

https://pmc.ncbi.nlm.nih.gov/articles/PMC5761954/

Study: Diabetic foot complications are among the most common and economically devastating problems associated with diabetes mellitus worldwide. This article examines the global financial burden of diabetic foot ulcers (DFUs), which result in massive economic crises for patients, families, and healthcare systems alike. DFUs have a neuropathic origin and show a... more
Focusing on Diabetic Ulcers

Focusing on Diabetic Ulcers

https://pmc.ncbi.nlm.nih.gov/articles/PMC7039261/

Study: Foot ulcers associated with diabetes mellitus require immediate attention due to the risk of amputation if left untreated. This brief but clinically focused article reviews the key mitigating risk factors and the physiopathology of the diabetic foot, while recounting a surgical approach from a vascular surgery unit in Naples, Italy.... more
IDF Diabetes Facts & Figures (International Diabetes Federation)

IDF Diabetes Facts & Figures (International Diabetes Federation)

https://idf.org/about-diabetes/diabetes-facts-figures/

Study: The International Diabetes Federation (IDF) Diabetes Facts & Figures page is the world’s leading continuously updated resource for global diabetes prevalence, incidence, and projections. According to the IDF’s most recent Atlas, approximately 589 million adults worldwide were living with diabetes in 2024 — a figure projected to rise to 853... more
Innovative Treatment Utilizing An Autologous Blood Clot For Diabetic Foot Ulcers

Innovative Treatment Utilizing An Autologous Blood Clot For Diabetic Foot Ulcers

https://pubmed.ncbi.nlm.nih.gov/35881826/

Study: Diabetic Foot Ulcer (DFU) is among the most common complications of uncontrolled diabetes. It is estimated that approximately 15% to 25% of patients with diabetes will develop a DFU in their lifetime. A DFU is a complex wound that requires considerable effort to restart a stalled healing process. In this... more
Mortality After Nontraumatic Major Amputation Among Patients With Diabetes and Peripheral Vascular Disease: A Systematic Review

Mortality After Nontraumatic Major Amputation Among Patients With Diabetes and Peripheral Vascular Disease: A Systematic Review

https://pubmed.ncbi.nlm.nih.gov/26898398/

Study: High mortality rates following major lower-limb amputations in patients with diabetes and peripheral vascular disease (PVD) have been reported across the literature, but rates have varied considerably between studies. This systematic review was conducted to consolidate five-year mortality data following nontraumatic major lower-extremity amputations. A search of Medline via OVID,... more
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

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

https://pubmed.ncbi.nlm.nih.gov/12766127/

Study: This landmark prospective study examined whether the four-week healing rate could predict complete wound closure at 12 weeks in patients with diabetic foot ulcers. Wound area measurements at baseline and at four weeks were obtained from 203 patients enrolled in a multicenter, randomized controlled trial. The midpoint percentage area reduction... more
Potential Cost-Effectiveness of Using Adjunctive Dehydrated Human Amnion/Chorion Membrane Allograft in the Management of Non-Healing Diabetic Foot Ulcers in the United Kingdom

Potential Cost-Effectiveness of Using Adjunctive Dehydrated Human Amnion/Chorion Membrane Allograft in the Management of Non-Healing Diabetic Foot Ulcers in the United Kingdom

https://pmc.ncbi.nlm.nih.gov/articles/PMC8613389/

Study: This study estimates the cost-effectiveness of using dehydrated human amnion/chorion membrane (dHACM) allografts (Epifix) as an adjunct to standard care, compared with standard care alone, to manage non-healing diabetic foot ulcers (DFUs) in secondary care in the United Kingdom, from the perspective of the National Health Service (NHS). A Markov... more
Proposed Mechanism Of Action Of Topically Applied Autologous Blood Clot Tissue: A Quintessential Cellular And Tissue Based Therapy

Proposed Mechanism Of Action Of Topically Applied Autologous Blood Clot Tissue: A Quintessential Cellular And Tissue Based Therapy

https://doi.org/10.7547/20-140

Study: The topically applied autologous blood clot tissue creates a scaffold that serves as a biologic delivery system that functions to control the release of growth factors and cytokines. Activated platelets and fibrin set forth the groundwork of the scaffold via conformational change and cleavage. Platelets provide immunity to the wound... more
Real-world outcomes of autologous whole blood clot therapy for venous leg ulcers

Real-world outcomes of autologous whole blood clot therapy for venous leg ulcers

https://www.magonlinelibrary.com/doi/abs/10.12968/jowc.2025.0419

Study: Venous leg ulcers (VLUs) are hard-to-heal wounds primarily caused by venous insufficiency and venous hypertension. These wounds pose significant clinical and economic burdens, often failing to heal with standard compression therapy alone. Autologous whole blood clot (AWBC) therapy has emerged as a potential treatment for hard-to-heal wounds, complementing the body’s... more
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

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

https://pubmed.ncbi.nlm.nih.gov/29718812/

Study: The use of an autologous blood clot product on neuropathic DFUs was found to be safe and efficacious to use on patients with multiple, serious comorbidities. 2 of 32 adverse events (AEs) were deemed potentially device-related, however, treatment with the blood clot product continued once the AEs were resolved. Twenty... more
The Safety Of An Autologous Whole Blood Clot Product Applied To Full Thickness Dermal Wounds in A Porcine Model For Up To 18 Days

The Safety Of An Autologous Whole Blood Clot Product Applied To Full Thickness Dermal Wounds in A Porcine Model For Up To 18 Days

https://doi.org/10.2147/CWCMR.S189836

Study: Blood has become a major source for wound care products due to its primary role in wound healing. In this study, the safety of an autologous whole blood clot product was evaluated in porcine models. The blood clot provides a fibrin scaffold that serves as a protective, provisional extracellular matrix.... more
The Use Of ActiGraft, An Autologous Skin Graft, In The Treatment Of Complex Diabetes Foot Ulcer

The Use Of ActiGraft, An Autologous Skin Graft, In The Treatment Of Complex Diabetes Foot Ulcer

https://juniperpublishers.com/arr/pdf/ARR.MS.ID.555685.pdf

Study: This case study found ActiGraft to be a highly effective and cost-efficient wound care solution for treating chronic diabetic foot ulcers (DFUs). DFUs are a complication associated with many comorbidities that can result in long-term hospitalization, limb amputation, and even death. ActiGraft proved successful in treating a hard-to-heal, chronic DFU... more
The Use Of Active Coagulation Whole Blood – An Innovative Treatment Strategy For Hard-To-Heal Wounds

The Use Of Active Coagulation Whole Blood – An Innovative Treatment Strategy For Hard-To-Heal Wounds

https://reddressmedical.com/wp-content/uploads/2023/10/Haim-et-al-Flowable-2023.pdf

Study: Deep and tunneling wounds, hard-to-heal in nature, are a challenge to apply and maintain most advanced wound dressings to promote effective healing. An autologous whole blood clot is a topical treatment and has been found to be safe and effective in healing cutaneous wounds. The active coagulation whole blood (ACWB)... more
Topical Autologous Blood Clot Therapy: An Introduction and Development of Consensus Panel To Guide Use In The Treatment of Complex Wound Types

Topical Autologous Blood Clot Therapy: An Introduction and Development of Consensus Panel To Guide Use In The Treatment of Complex Wound Types

https://pubmed.ncbi.nlm.nih.gov/36219459/

Study: The complexity of a wound – whether it is acute or chronic – is based on patient-specific local, systemic, and psychosocial actors. A panel of providers experienced in wound care and surgical wound management was convened to create a series of publications on the use of topical autologous blood clot... more
Use Of An Autologous Matrix On Diabetic Foot Ulcers With Near-Infrared Spectroscopy And pH Measurement

Use Of An Autologous Matrix On Diabetic Foot Ulcers With Near-Infrared Spectroscopy And pH Measurement

https://pubmed.ncbi.nlm.nih.gov/33249991/

Study: The study aims to evaluate the efficiency of an autologous whole blood clot (WBC) matrix on diabetic foot ulcers (DFU), and analyse its immune response with near-infrared spectroscopy (NIRS) and pH measurement. The use of an autologous matrix was effective in healing three non-healing DFUs. Quantitative measurements taken with the... more
Use Of Autologous Whole Blood Clot In The Treatment Of Complex Surgical Wounds: A Case Series

Use Of Autologous Whole Blood Clot In The Treatment Of Complex Surgical Wounds: A Case Series

https://pubmed.ncbi.nlm.nih.gov/36744737

Study: A registry study of patients with surgical wounds was conducted to evaluate if an autologous blood clot, ActiGraft, can promote wound healing in complex surgical wounds. A total of 14 patients took part in the study. Autologous whole blood clot treatment resulted in a mean percent wound area reduction of... more
Utilization of A Topical Autologous Blood Clot for Treatment of Pressure Ulcers

Utilization of A Topical Autologous Blood Clot for Treatment of Pressure Ulcers

https://onlinelibrary.wiley.com/doi/pdf/10.1111/iwj.13927

Study: Management and treatment of pressure ulcers (PUs) are met with great difficulty due to various factors that cause vulnerability of the soft tissue such as location, limited mobility, increased friction and shearing forces, as well as other comorbidities that may delay or halt wound healing. This study aims to assess... more
Utilization Of ActiGraft, An Autologous (Blood Clot) Graft In The Reconstruction Of Soft Tissue Deficit From Hand Trauma – A Case Study

Utilization Of ActiGraft, An Autologous (Blood Clot) Graft In The Reconstruction Of Soft Tissue Deficit From Hand Trauma – A Case Study

https://juniperpublishers.com/arr/pdf/ARR.MS.ID.555692.pdf

Study: This case study found ActiGraft to be a safe and effective wound treatment which showed to be successful in treating a deep cutaneous injury on the patient’s hand. ActiGraft not only successfully repaired the skin deficit, but simultaneously mitigated scar formation while supporting good hand mobility. Data demonstrated a decrease... more
Utilization Of ActiGraft, An Autologous Whole Blood Clot, For Treatment Of Complex Wounds Linked To Comorbidities

Utilization Of ActiGraft, An Autologous Whole Blood Clot, For Treatment Of Complex Wounds Linked To Comorbidities

https://jcmimagescasereports.org/article/JCM-V3-1429.pdf

Study: A study was conducted to evaluate the efficacy of ActiGraft in treating complicated chronic wounds associated with various comorbidities including deep vein thrombosis post-cancer-related surgical wound, peripheral arterial disease, and Charcot foot. Severe comorbidities can have a major, negative effect on the wound healing process. Four patients with multiple comorbidities,... more