A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 8
- 主要终点
- Wound progress of the total effect of treatment using Mepilex Up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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
结局指标
主要结局
Wound progress of the total effect of treatment using Mepilex Up
时间窗: From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Wound progress is 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 by the treating investigator/designee. Wound progress will be assessed as deteriorated, no change, improved, or healed at each visit. Wound area will be measured by an independent evaluator assisted by digital software at each visit and recorded as cm2 using the formula, A= π\*L\*W/4.
次要结局
- Percentage wound area reduction over time(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(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)(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(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(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)(From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Status of dressing during a routine dressing change or complication(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Offloading Use/Type(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Compliance to offloading(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Wear time (days)(From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Debridement performed(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(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(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(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(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)(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(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Wound pain score during dressing wear over time (PRO)(From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Primary dressing's ability to be comfortable to wear (PRO)(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO)(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Evaluation of Wound Quality of Life (QoL) (PRO)(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Pre-compression edema(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO)(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Technical Performance (Investigator/designee's evaluation)(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Compliance with compression(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Compression removed/changed/applied(A maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Cleansing performed(From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.)
- Evaluation of all reported adverse events and device deficiencies(From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.)