A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Официальное название

A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing

Обзор

The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Подробное описание

This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using the non-bordered foam dressing as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. The only included indication is Venous Leg Ulcers (VLU). A total of n=20 participants will be recruited at up to 6 centers within the US and Canada.

There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.

Вмешательства

• Устройство ALLEVYN Non-Adhesive
  ALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction. ALLEVYN Non-Adhesive consists of the following layers: * Breathable top film * Highly absorbent foam core * Non-adhesive wound conta

Первичные конечные точки

• Wound progress of the total effect of treatment using ALLEVYN Non-Adhesive [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]

Вторичные конечные точки (12)

• Percentage wound area reduction over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Linear wound healing over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Change in granulation tissue over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Change in sloughy tissue over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Change in exudate amount over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Change in exudate nature over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Change in peri-wound skin condition over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Change in maceration over time [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Wound/Peri-Wound itch score prior to dressing removal over time (PRO) [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Wound pain score during dressing wear over time (PRO) [Срок оценки: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Wound pain score related to removal of dressing over time (PRO) [Срок оценки: A maximum total treatment period of 44 days or until healed, whichever occurs first.]
• Trauma to the wound/peri-wound during dressing removal over time [Срок оценки: A maximum total treatment period of 44 days or until healed, whichever occurs first.]

Критерии участия

Критерии включения

• Signed consent to participate (including consent for digital imaging)
• Adult aged ≥18 years
• Diagnosed with a chronic, exuding VLU
• Exudate amount moderate to large
• Wound size from 3 cm2 to 30 cm2, as determined by the clinician
• ABPI (within 3 months) > 0.7. If ABPI > 1.4, then big toe pressure > 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
• Willing to be compliant with compression therapy

Критерии исключения

• Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
• Circumferential wound
• Known allergy/hypersensitivity to the materials of the dressing
• Use of wound fillers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Center for Clinical Trials, Inc. — San Francisco
• University of Miami — Miami
• Serena Group Research Institute — Pittsburgh

Публикации

• Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney J, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future PMID 25486905
• Rippon M WM, Bielfeldt S. An evaluation of properties related to wear time of four dressings during a five-day period. Wounds UK. 2015;11(1):45-54.
• Tickle J. Wound exudate: a survey of current understanding and clinical competency. Br J Nurs. 2016 Jan 28-Feb 10;25(2):102-9. doi: 10.12968/bjon.2016.25.2.102. PMID 27119542
• Young T, Clark M, Augustin M, Carville K, Curran J, Flour M, et al. International consensus. Optimising wellbeing in people living with a wound. An expert working group review. Wounds International; London 2012.
• Chadwick P, McCardle J. Exudate management using a gelling fibre dressing. The Diabetic Foot Journal. 2015;18(1):43-8.
• Gonzalez de la Torre H, Quintana-Lorenzo ML, Perdomo-Perez E, Verdu J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017 Apr;14(2):360-368. doi: 10.1111/iwj.12610. Epub 2016 Apr 25. PMID 27112627
• Jones JE, Robinson J, Barr W, Carlisle C. Impact of exudate and odour from chronic venous leg ulceration. Nurs Stand. 2008 Jul 16-22;22(45):53-4, 56, 58 passim. doi: 10.7748/ns2008.07.22.45.53.c6592. PMID 18686695
• World Union of Wound Healing Societies (WUWHS). Principles of best practice: Wound exudate and the role of dressings. A consensus document. 2019.

Идентификаторы

NCT: NCT05608317 · DIPLO NBF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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