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J Vasc Surg Venous Lymphat Disord. 2019 Mar;7(2):228-233. doi: 10.1016/j.jvsv.2018.09.016. Epub 2019 Jan 6.

Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers.

Author information

1
Division of Vascular Surgery, Department of Surgery, Cleveland Clinic, Cleveland, Ohio.
2
Division of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine and Baltimore Veterans Administration Medical Center, Baltimore, Md.
3
Division of Vascular Surgery, Department of Surgery, University of Maryland School of Medicine and Baltimore Veterans Administration Medical Center, Baltimore, Md. Electronic address: blal@som.umaryland.edu.

Abstract

OBJECTIVE:

Chronic venous leg ulcers (VLUs) affect up to 2% of the general population, resulting in a significant socioeconomic burden. Placental tissue that contains mesenchymal stem cells and active growth factors has been shown to be beneficial in healing of chronic wounds. We compared the efficacy of a human viable wound matrix (hVWM) of cryopreserved placental tissue for the treatment of refractory VLUs with standard therapy.

METHODS:

This prospective single-center open-label single-arm study enrolled patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C6 VLUs. The ulcers of all enrolled patients had failed to heal after a trial of standard therapy of at least 12 weeks, which included weekly multilayer compression therapy along with local wound care. The same patients subsequently received application of hVWM (Grafix; Osiris Therapeutics, Columbia, Md) every 1 to 2 weeks in addition to standard therapy. Healing with hVWM therapy was then compared with standard therapy, with each patient serving as his own control.

RESULTS:

There were 30 VLUs in 21 consecutive eligible patients who were enrolled in the study. All patients were men with an average age of 67 years (standard deviation [SD], ±10.8 years), and the average area of venous ulcers before hVWM initiation was 12.2 cm2 (SD, ±14.6 cm2; range, 3.3-12.3 cm2). Duplex ultrasound confirmed superficial or deep system venous reflux in all patients. Complete ulcer healing was achieved in 53% (16/30) of VLUs refractory to standard therapy after application of hVWM. There was a mean reduction in wound surface area by 79% (SD, ±27.3%; P < .001 compared with standard therapy) after a mean treatment time of 10.9 weeks. Eighty percent of VLUs were reduced in size by half compared with 25% with standard therapy (P < .001). The mean rate of reduction in ulcer area after hVWM applications was 1.69% per day vs 0.73% per day with standard therapy (P = .01).

CONCLUSIONS:

Cryopreserved placental tissue (hVWM) improves healing processes to achieve complete wound closure in a significant proportion of chronic VLUs refractory to standard therapy. Adjunctive therapy with hVWM provides superior healing rates in refractory VLUs.

KEYWORDS:

Compression; Placental tissue; Venous insufficiency; Venous ulcer; Wound matrix

PMID:
30621916
DOI:
10.1016/j.jvsv.2018.09.016

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