A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

Официальное название

A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up

Обзор

The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. 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 Mepilex Up 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 exuding 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 Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. Two indications will be included: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcers (DFU). A total of n=68 participants, approximately 34 per indication, will be recruited at up to 8 centers in the US.

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 Mepilex Up
  Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal. Mepilex Up consists of: * a soft silicone wound contact layer (Safetac) * a flexible absorbent pad of compressed polyurethane foam * an outer polyur

Первичные конечные точки

• Wound progress of the total effect of treatment using Mepilex Up [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.]
• Percentage wound volume reduction over time (DFUs only) [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.]

Критерии участия

Критерии включения

• Signed consent to participate (including consent for digital imaging)
• Adult aged ≥18 years
• Diagnosed with a chronic, exuding VLU or DFU
• Exudate amount moderate to large
• Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
• For VLU: 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
• For VLU: 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
• Patients participating in the DIPLO NBF study
• 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 · 4 центра

• Center for Clinical Research, Inc. — Castro Valley
• Felix Sigal, DPM — Los Angeles
• 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
• 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
• 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
• Maume S, Van De Looverbosch D, Heyman H, Romanelli M, Ciangherotti A, Charpin S. A study to compare a new self-adherent soft silicone dressing with a self-adherent polymer dressing in stage II pressure ulcers. Ostomy Wound Manage. 2003 Sep;49(9):44-51. PMID 14581709
• Moore Z, Strapp H. Managing the problem of excess exudate. Br J Nurs. 2015 Aug 13-Sep 19;24(15):S12, S14-7. doi: 10.12968/bjon.2015.24.Sup15.S12. PMID 26266558
• Rippon M, Davies P, White R. Taking the trauma out of wound care: the importance of undisturbed healing. J Wound Care. 2012 Aug;21(8):359-60, 362, 364-8. doi: 10.12968/jowc.2012.21.8.359. PMID 22885308
• Gorin DR, Cordts PR, LaMorte WW, Manzoian JO. The influence of wound geometry on the measurement of wound healing rates in clinical trials. J Vasc Surg. 1996 Mar;23(3):524-8. doi: 10.1016/s0741-5214(96)80021-8. PMID 8601898

Идентификаторы

NCT: NCT05588583 · DIPLO01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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