Clinical Evidence

Confidence Begins with Evidence 

Explore the clinical data supporting LifeNet Health Regenerative Wound Solutions. 

At LifeNet Health, our commitment to advancing wound care is grounded in clinical evidence. Our portfolio is supported by randomized controlled trials, real-world studies, and health economics analyses demonstrating meaningful outcomes across diabetic foot ulcers, venous leg ulcers, complex wounds, and surgical reconstruction. 

Because confident decisions start with proven results.

Key Clinical Evidence by Product

Dermacell^® (AWM & Porous)

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. 
Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA.  Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0. PMID: 31361269; PMCID: PMC7328871. 

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.  
Cazzell, S., Vayser, D., Pham H., et al. Wound Repair and Regeneration. 2017. 

Health Economics of Skin Substitutes for Treatment of Diabetic Foot Ulcers: A Cost-Effectiveness Analysis of Eight Skin Substitutes. 
Samsell B, McLean J, Cazzell S, Dorsch K, Moyer P, Moore M. J Wound Care. 2019;28(Sup9):S14-26. 

Evaluation of host tissue integration, revascularization, and cellular infiltration within various dermal substrates.  
Capito AE, Tholpady SS, Agrawal H, Drake DB, Katz AJ. Ann Plast Surg. 2012 May;68(5):495-500. doi: 10.1097/SAP.0b013e31823b6b01. PMID: 22531405. 

Effectiveness and safety of dermal matrix used for diabetic foot ulcer: a systematic review and meta-analysis of randomized controlled trials. 
Sui, L., Xie, Q., Jiang, H. T., & Li, X. D. (2024). BMC Endocrine Disorders, 24(1), 23.

TheraSkin^®

Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers.  
Armstrong DG, Galiano RD, Orgill DP, Glat PM, Carter MJ, Di Domenico LA, Reyzelman AM, Zelen CM. Int Wound J. 2022 May;19(4):932-944. doi: 10.1111/iwj.13759. Epub 2022 Jan 26. Erratum in: Int Wound J. 2022 Aug;19(5):1276. doi: 10.1111/iwj.13841. PMID: 35080127; PMCID: PMC9013597.

Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions.  
Barbul A, Gurtner GC, Gordon H, Bakewell K, Carter MJ. Wound Repair Regen. 2020;28(1):81-9. doi:10.1111/wrr.12767.

Randomized, Prospective, Blinded-Enrollment, Head-To-Head Venous Leg Ulcer Healing Trial Comparing Living, Bioengineered Skin Graft Substitute (Apligraf) with Living, Cryopreserved, Human Skin Allograft (TheraSkin).  
Towler MA, Rush EW, Richardson MK, Williams CL. Clin Podiatr Med Surg. 2018 Jul;35(3):357-365. doi: 10.1016/j.cpm.2018.02.006. Epub 2018 Apr 14. PMID: 29861018.

A prospective comparison of diabetic foot ulcers treated with either a cryopreserved skin allograft or a bioengineered skin substitute.  
DiDomenico L, Landsman AR, Emch KJ, Landsman A. Wounds. 2011 Jul;23(7):184-9. PMID: 25879172.

Characterization of a cryopreserved split-thickness human skin allograft-TheraSkin.  
Landsman A, Rosines E, Houck A, et al. Adv Skin Wound Care. 2016;29(9):399-406. doi:10.1097/01.ASW.0000489991.32684.9e.

Matrion^®

Efficacy of a full-thickness decellularised placental membrane allograft compared to standard of care in diabetic foot ulcers: a prospective, randomised controlled trial.  
Reyzelman AM, Vayser D, Hanft JR, Cazzell S, Surprenant MS, Chiu H, Moyer PM, Ducharme S, Tovmassian G. J Wound Care. 2025 Oct 2;34(10):836-846. doi: 10.12968/jowc.2025.0428. Epub 2025 Oct 7. PMID: 41071302.

Comparative Effectiveness of Amniotic and Chorionic Grafts in the Treatment of Lower Extremity Diabetic Ulcers Using US Medicare Real-World Evidence (2018-2022): A Retrospective Observational Cohort.  
Padula, W. V., Ramanathan, S., Cohen, B. G., Chingcuanco, F., Steel, P., & Herzer, K. R. Available at SSRN 4859518.

Placental membrane grafts for urethral replacement in a rabbit model: a pilot study.  
Pusateri CR, Doudt AD, Gauerke S, McCammon K, Qin X, Ork B, Khoury JM, May AD, Zuckerman JM. World J Urol. 2020 Sep;38(9):2133-2138. DOI: 10.1007/s00345-019-02836-1

Characterization of a full-thickness decellularized and lyophilized human placental membrane for clinical applications.  
Wetzell B, Ork B, Softic D, et al. Int Wound J. 2024;21(5):e14888. doi:10.1111/iwj.14888

TheraGenesis^®

Selection of Artificial Dermis for Shortening Treatment Period: Integra versus Pelnac.  
Kashimura T, Nagasaki K, Horigome M, Yoshida K, Soejima K. Plast Reconstr Surg Glob Open. 2021 Jun 10;9(6):e3599. doi: 10.1097/GOX.0000000000003599. PMID: 34123683; PMCID: PMC8191699.

Influence of glycosaminoglycans on the collagen sponge component of a bilayer artificial skin.  
Matsuda, K., Suzuki, S., Isshiki, N., Yoshioka, K., Okada, T., & Ikada, Y. (1990). Biomaterials, 11(5), 351–355. https://doi.org/10.1016/0142-9612(90)90113-5

Comparative experimental study of wound healing in mice: Pelnac versus Integra.  
Wosgrau AC, Jeremias Tda S, Leonardi DF, Pereima MJ, Di Giunta G, Trentin AG. PLoS One. 2015 Mar 23;10(3):e0120322. DOI: 10.1371/journal.pone.0120322

One-stage Pelnac Reconstruction in Full-thickness Skin Defects with Bone or Tendon Exposure.  
Lou X, Xue H, Li G, Wang K, Zhou P, Li B, Chen J. Plast Reconstr Surg Glob Open. 2018 Mar 21;6(3):e1709. doi: 10.1097/GOX.0000000000001709

Treatment of finger degloving injury with acellular dermal matrices: Functional and aesthetic results.  
Maruccia M, Marannino PC, Elia R, Ribatti D, Tamma R, Nacchiero E, Manrique OJ, Giudice G. J Plast Reconstr Aesthet Surg. 2019 Sep;72(9):1509-1517. DOI: 10.1016/j.bjps.2019.05.029