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Treatment of Chronic Nonhealing Leg Ulceration with Gaseous Nitric Oxide: A Case Study

  • Case Report
  • Published:
Journal of Cutaneous Medicine and Surgery

Abstract

Background

Despite the best clinical practice, chronic nonhealing ulcers of the lower extremities present a significant challenge. Nitric oxide (NO) has been shown to play a significant role in biological functions including wound healing and as an antimicrobial agent in nonspecific immune response.

Objective

Our goal was to study the effect of gaseous NO (gNO) administered directly to a two-year-old nonhealing chronic venous ulcer in a 55-year-old male presenting with a 30-year history of severe venous disease.

Methods

gNO (200 ppm) was applied to the lower extremity using a delivery system connected to a “single patient use” plastic boot, at 1.0 L/min.

Results

The patient received an average of 8.1-h treatments for 14 consecutive nights. On day 0 the wound was malodorous and covered by bacterial biofilm with little healthy granulation tissue present. Following 3 days of gNO treatment, healthy granulation tissue was noted with absence of malodorous odor. At day 14, the ulcer was significantly reduced in size (p = 0.014) and almost completely reepithelialized. Day 10 post-treatment did not reveal any deterioration in healing. Six weeks later, the wound was 90% healed. At 26 weeks post gNO discontinuation, the ulcer was completely healed.

Conclusions

This single case study demonstrated that gNO as a topical agent was well tolerated by the patient without any report of discomfort or side effect. The result of wound healing was very promising and warrants future exploration.

Sommaire

Antécédents

Malgré les meilleures pratiques cliniques, les ulcères chroniques non guérissables des membres inférieurs représèntent un défi de taille. Il a été démontré que le monoxyde d’azote (NO) joue un rôle important dans les fonctions biologiques, notamment la cicatrisation des plaies, et agit comme agent antimicrobien dans les réponses immunitaires aspécifiques.

Objectif

Administrer du NO gazeux directement sur un ulcère veineux chronique non guérissable de deux ans, chez un patient âgé de 55 ans souffrant de maladies veineuses graves depuis 30 ans.

Methodes

200 ppm de NO gazeux ont été appliqués sur les membres inférieurs au moyen d’un système de livraison connecté à des bottes en plastique à usage unique, à 1lpm

Résultats

Le traitement de 14 nuits consécutives a nécessité en moyenne 8,1 heures. Au jour 0, la plaie était malodorante et couverte de mucilage bactérien, avec peu de tissu de granulation sain. Après trois jours de traitement au NO gazeux, on a noté la présence de tissu de granulation sain avec une absence de mauvaise odeur. Au jour 14, la taille de 1’ulcère a été réduite considérablement (p = 0,014) et une réépithélialisation presque complète a eu lieu. Au jour 10 après la fin du traitement, aucun signe de détérioration n’a été détecté. Six semaines plus tard, la plaie était guérie à 90 %. À la 26e semaine suivant la fin du traitement, l’ulcére était complétement guéri.

Conclusion

Ce cas unique montre que le NO gazeux comme médicament topique a été bien toléré par le patient sans mention de sensations gênantes ni d’effets secondaires. Les résultats de la guérison sont très prometteurs et méritent une exploration plus poussée.

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Acknowledgments

We would like to thank the team at Pulmonox for their support of this study, in particular Mr. Robert Lee and Bruce Murray for their expert technical assistance in construction of the device. We would also like to thank Alex Stenzler of Viasys Healthcare for his invaluable input and encouragement.

Chris Miller currently is employed as CEO of PulmoNOx Medical Inc. Minna Miller is related to Chris Miller.

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Correspondence to Chris C. Miller.

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Miller, C.C., Miller, M.K., Ghaffari, A. et al. Treatment of Chronic Nonhealing Leg Ulceration with Gaseous Nitric Oxide: A Case Study. J Cutan Med Surg 8, 233–238 (2004). https://doi.org/10.1007/s10227-004-0106-8

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  • DOI: https://doi.org/10.1007/s10227-004-0106-8

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