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

Primary Purpose

Wounds, Wound of Skin, Wound Leg

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mepilex Up
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wounds focused on measuring Diabetic Foot Ulcer, Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Center for Clinical Research, Inc.Recruiting
  • Felix Sigal, DPMRecruiting
  • University of MiamiRecruiting
  • Serena Group Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care with Mepilex Up

Arm Description

All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing.

Outcomes

Primary Outcome Measures

Wound progress of the total effect of treatment using Mepilex Up
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.

Secondary Outcome Measures

Percentage wound area reduction over time
The percentage of wound area (cm2) reduction over time will be assessed by a formula as the area of an ellipse and measured by an independent evaluator assisted by digital software on all digital photographs taken at each scheduled visit.
Percentage wound volume reduction over time (DFUs only)
The percentage wound volume (cm3) reduction over time will be calculated by a formula from the manually assessed wound depth and the digitally assessed wound area.
Linear wound healing over time
The linear wound healing will be calculated with Gilman's formula (cm/day), G = - (A1-A0)/ {[(P1+P0)/2]*(t1-t0)}, where: A0 = previous visit area A1 = current visit area P0 = previous visit perimeter P1 = current visit perimeter t0 = previous visit time t1 = current visit time. Area (A) and Perimeter (P) will be assessed by an independent evaluator assisted by digital software. Perimeter (P) will be measured in cm and Area (A) will be assessed in cm2.
Change in granulation tissue over time
The area of wound covered by granulation tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Change in sloughy tissue over time
The area of wound covered by sloughy tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Change in exudate amount over time
Exudate amount will be captured as a subjective measure from the investigator/designee and assessed as none, scant, small, moderate, or large.
Change in exudate nature over time
Exudate nature will be captured as a subjective measure from the investigator/designee via the following category descriptive scale: serous, serosanguinous, sanguineous, seropurulent, fibrinous, purulent, hemopurulent, or hemorrhagic.
Change in peri-wound skin condition over time
The change in peri-wound skin condition over time will be assessed by visual assessment (No/Yes) by investigator/designee for maceration, dry skin, erythema/redness, and other peri-wound skin conditions. The Transepidermal Water Loss, or TEWL, will be an additional variable assessed at every visit for VLU Subjects at a limited number of clinical sites. TEWL measurements will be done using a portable VapoMeter.
Change in maceration over time
Area of wound covered by macerated tissue (%) will be assessed before debridement in cm2 by an independent evaluator assisted by digital software. The maximal distance (cm) from as close to the wound edge as possible to the end of maceration, assessed from wound photo, taken before debridement, by an independent evaluator assisted by digital software. The area of maceration will be assessed from a wound photo taken before debridement by an independent evaluator assisted by digital software.
Wound/Peri-Wound itch score prior to dressing removal over time (PRO)
The Subject itch severity before dressing removal over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates their level of itchiness on a level from 0 to 10, where 0 indicates no itch and 10 is the worst itch.
Wound pain score during dressing wear over time (PRO)
Subject pain severity during dressing wear over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain.
Wound pain score related to removal of dressing over time (PRO)
Subject pain severity at dressing removal will be assessed at all follow-up visits using the NRS scale where the Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain. Any pre-procedural or intra-procedural pain medication administered at the time of dressing removal will be recorded.
Trauma to the wound/peri-wound during dressing removal over time
Trauma to the wound will be captured via visual judgement by the investigator/desginee using an ordinal scale of none, very slight, moderate, or high. Trauma to the peri-wound skin will be captured via visual judgement by the investigator/designee using the ordinal scale of none, very slight, moderate, or high.
Primary dressing's ability to be comfortable to wear (PRO)
Subjects will be asked to rate Mepilex Up degree of comfort using a 4-item scale of very poor, poor, good, or very good.
For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO)
VLU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with compression using a 4-item scale of very poor, poor, good, or very good.
For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO)
DFU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with offloading using a 4-item scale of very poor, poor, good, or very good.
Evaluation of Wound Quality of Life (QoL) (PRO)
A Wound-QoL-17 questionnaire will be completed by each Subject to measure the disease-specific, health-related QoL of those with chronic wounds. All items assess impairments within the preceding seven days.
Technical Performance (Investigator/designee's evaluation)
Several questions will be asked to evaluate the technical performance properties of Mepilex Up. The following will be assessed by the investigator/designee using no/yes values: 1) Occurrence of strike-through, defined as the inability of the dressing to stay sealed over the wound causing leakage of wound exudate; and 2) Occurrence of product residue in the wound bed or on peri-wound skin after dressing removal. All other properties will be assessed by the investigator/designee using a 4-item scale of very poor, poor, good, very good. These include: Ability to absorb exudates with different viscosities, Ability to retain exudate, Ease of application, Ability to conform to the wound during wear, Ability to be repositioned during application, Inability to adhere to moist wound bed, Ability to adhere to healthy, intact skin, Ability to stay on during application and use, Overall satisfaction with the dressing's properties.
Status of dressing during a routine dressing change or complication
The status of Mepilex Up during a routine dressing change or complication will be assessed by the investigator/designee as strike-through, saturated, displaced/slipping, or other. This will be recorded in the Dressing Log.
Pre-compression edema
The specification of any pre-compression edema prior to applying/changing compression therapy will be assessed by the investigator/designee as: 0 (no clinical edema) 1+ (≤2 mm indentation) 2+ (2-4 mm indentation) 3+ (4-6 mm indentation) 4+ (6-8 mm indentation)
Compression removed/changed/applied
Assessment of compression by the investigator/designee will cover: Compression removal (No/Yes) Compression changed/applied (No/Yes) Type of compression used
Compliance with compression
The investigator/designee will evaluate Subject compliance with compression. Assessment will include being fully compliant (defined as 7 out of 7 days with compression), moderately compliant (defined as 1 to 3 days without compression out of 7 days), or not compliant (defined as >3 days without compression out of 7 days).
Offloading Use/Type
The assessment of offloading will cover if it were used (No/Yes) and specification of offloading type by the investigator/designee.
Compliance to offloading
The investigator/designee will evaluate Subject compliance with offloading. Assessment will include being fully compliant (defined as 7 out of 7 days with offloading), moderately compliant (defined as 1 to 3 days without offloading out of 7 days), or not compliant (defined as >3 days without offloading out of 7 days).
Wear time (days)
Wear time will be determined from the Subject Dressing Log at each visit by collecting: Date of dressing application/change Reason for change application/change Lot/batch Size Quantity
Debridement performed
The following debridement details will be recorded for each Subject at each visit: Debridement performed (No/Yes) Debridement method Ease of debridement (Very easy/Easy/Difficult/Very Difficult)
Cleansing performed
The following cleansing details will be recorded for each Subject at each visit: Cleansing performed (No/Yes) Type of cleansing agent used
Evaluation of all reported adverse events and device deficiencies
If any reported adverse events or device deficiencies are reported, an evaluation will take place to determine root cause.

Full Information

First Posted
October 14, 2022
Last Updated
April 18, 2023
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT05588583
Brief Title
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
Official Title
A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Wound of Skin, Wound Leg, Wound; Foot, Diabetic Foot Ulcer, Venous Leg Ulcer
Keywords
Diabetic Foot Ulcer, Venous Leg Ulcer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The model is 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care with Mepilex Up
Arm Type
Experimental
Arm Description
All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing.
Intervention Type
Device
Intervention Name(s)
Mepilex Up
Intervention Description
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 polyurethane film which is breathable but waterproof Dressing material content: Silicone, polyurethane
Primary Outcome Measure Information:
Title
Wound progress of the total effect of treatment using Mepilex Up
Description
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.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Secondary Outcome Measure Information:
Title
Percentage wound area reduction over time
Description
The percentage of wound area (cm2) reduction over time will be assessed by a formula as the area of an ellipse and measured by an independent evaluator assisted by digital software on all digital photographs taken at each scheduled visit.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Percentage wound volume reduction over time (DFUs only)
Description
The percentage wound volume (cm3) reduction over time will be calculated by a formula from the manually assessed wound depth and the digitally assessed wound area.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Linear wound healing over time
Description
The linear wound healing will be calculated with Gilman's formula (cm/day), G = - (A1-A0)/ {[(P1+P0)/2]*(t1-t0)}, where: A0 = previous visit area A1 = current visit area P0 = previous visit perimeter P1 = current visit perimeter t0 = previous visit time t1 = current visit time. Area (A) and Perimeter (P) will be assessed by an independent evaluator assisted by digital software. Perimeter (P) will be measured in cm and Area (A) will be assessed in cm2.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Change in granulation tissue over time
Description
The area of wound covered by granulation tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Change in sloughy tissue over time
Description
The area of wound covered by sloughy tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Change in exudate amount over time
Description
Exudate amount will be captured as a subjective measure from the investigator/designee and assessed as none, scant, small, moderate, or large.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Change in exudate nature over time
Description
Exudate nature will be captured as a subjective measure from the investigator/designee via the following category descriptive scale: serous, serosanguinous, sanguineous, seropurulent, fibrinous, purulent, hemopurulent, or hemorrhagic.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Change in peri-wound skin condition over time
Description
The change in peri-wound skin condition over time will be assessed by visual assessment (No/Yes) by investigator/designee for maceration, dry skin, erythema/redness, and other peri-wound skin conditions. The Transepidermal Water Loss, or TEWL, will be an additional variable assessed at every visit for VLU Subjects at a limited number of clinical sites. TEWL measurements will be done using a portable VapoMeter.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Change in maceration over time
Description
Area of wound covered by macerated tissue (%) will be assessed before debridement in cm2 by an independent evaluator assisted by digital software. The maximal distance (cm) from as close to the wound edge as possible to the end of maceration, assessed from wound photo, taken before debridement, by an independent evaluator assisted by digital software. The area of maceration will be assessed from a wound photo taken before debridement by an independent evaluator assisted by digital software.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Wound/Peri-Wound itch score prior to dressing removal over time (PRO)
Description
The Subject itch severity before dressing removal over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates their level of itchiness on a level from 0 to 10, where 0 indicates no itch and 10 is the worst itch.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Wound pain score during dressing wear over time (PRO)
Description
Subject pain severity during dressing wear over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Wound pain score related to removal of dressing over time (PRO)
Description
Subject pain severity at dressing removal will be assessed at all follow-up visits using the NRS scale where the Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain. Any pre-procedural or intra-procedural pain medication administered at the time of dressing removal will be recorded.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Trauma to the wound/peri-wound during dressing removal over time
Description
Trauma to the wound will be captured via visual judgement by the investigator/desginee using an ordinal scale of none, very slight, moderate, or high. Trauma to the peri-wound skin will be captured via visual judgement by the investigator/designee using the ordinal scale of none, very slight, moderate, or high.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Primary dressing's ability to be comfortable to wear (PRO)
Description
Subjects will be asked to rate Mepilex Up degree of comfort using a 4-item scale of very poor, poor, good, or very good.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO)
Description
VLU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with compression using a 4-item scale of very poor, poor, good, or very good.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO)
Description
DFU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with offloading using a 4-item scale of very poor, poor, good, or very good.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Evaluation of Wound Quality of Life (QoL) (PRO)
Description
A Wound-QoL-17 questionnaire will be completed by each Subject to measure the disease-specific, health-related QoL of those with chronic wounds. All items assess impairments within the preceding seven days.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Technical Performance (Investigator/designee's evaluation)
Description
Several questions will be asked to evaluate the technical performance properties of Mepilex Up. The following will be assessed by the investigator/designee using no/yes values: 1) Occurrence of strike-through, defined as the inability of the dressing to stay sealed over the wound causing leakage of wound exudate; and 2) Occurrence of product residue in the wound bed or on peri-wound skin after dressing removal. All other properties will be assessed by the investigator/designee using a 4-item scale of very poor, poor, good, very good. These include: Ability to absorb exudates with different viscosities, Ability to retain exudate, Ease of application, Ability to conform to the wound during wear, Ability to be repositioned during application, Inability to adhere to moist wound bed, Ability to adhere to healthy, intact skin, Ability to stay on during application and use, Overall satisfaction with the dressing's properties.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Status of dressing during a routine dressing change or complication
Description
The status of Mepilex Up during a routine dressing change or complication will be assessed by the investigator/designee as strike-through, saturated, displaced/slipping, or other. This will be recorded in the Dressing Log.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Pre-compression edema
Description
The specification of any pre-compression edema prior to applying/changing compression therapy will be assessed by the investigator/designee as: 0 (no clinical edema) 1+ (≤2 mm indentation) 2+ (2-4 mm indentation) 3+ (4-6 mm indentation) 4+ (6-8 mm indentation)
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Compression removed/changed/applied
Description
Assessment of compression by the investigator/designee will cover: Compression removal (No/Yes) Compression changed/applied (No/Yes) Type of compression used
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Compliance with compression
Description
The investigator/designee will evaluate Subject compliance with compression. Assessment will include being fully compliant (defined as 7 out of 7 days with compression), moderately compliant (defined as 1 to 3 days without compression out of 7 days), or not compliant (defined as >3 days without compression out of 7 days).
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Offloading Use/Type
Description
The assessment of offloading will cover if it were used (No/Yes) and specification of offloading type by the investigator/designee.
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Compliance to offloading
Description
The investigator/designee will evaluate Subject compliance with offloading. Assessment will include being fully compliant (defined as 7 out of 7 days with offloading), moderately compliant (defined as 1 to 3 days without offloading out of 7 days), or not compliant (defined as >3 days without offloading out of 7 days).
Time Frame
A maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Wear time (days)
Description
Wear time will be determined from the Subject Dressing Log at each visit by collecting: Date of dressing application/change Reason for change application/change Lot/batch Size Quantity
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Debridement performed
Description
The following debridement details will be recorded for each Subject at each visit: Debridement performed (No/Yes) Debridement method Ease of debridement (Very easy/Easy/Difficult/Very Difficult)
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Cleansing performed
Description
The following cleansing details will be recorded for each Subject at each visit: Cleansing performed (No/Yes) Type of cleansing agent used
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Title
Evaluation of all reported adverse events and device deficiencies
Description
If any reported adverse events or device deficiencies are reported, an evaluation will take place to determine root cause.
Time Frame
From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Kandrevas, MD, MS
Phone
734-358-2174
Email
janet.kandrevas@molnlycke.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Picchietti, MS, CCRA
Phone
260-258-3879
Email
andrea.picchietti@molnlycke.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD, MAS
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Research, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayana Sarkisova, CCRC
Phone
800-363-1069
Ext
104
Email
gayana@ccr-trials.com
First Name & Middle Initial & Last Name & Degree
Alexander Reyzelman, DPM
Facility Name
Felix Sigal, DPM
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maira Jackson, MA
Email
maira@lafootpain.com
First Name & Middle Initial & Last Name & Degree
Felix Sigal, DPM
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliette Espinosa
Phone
305-689-3376
Email
a.espinosa2@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Hadar Lev-Tov, MD
Facility Name
Serena Group Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Serena
Phone
412-335-0764
Email
lserena@serenagroups.com
First Name & Middle Initial & Last Name & Degree
Thomas Serena, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25486905
Citation
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 research. Wound Repair Regen. 2015 Jan-Feb;23(1):1-13. doi: 10.1111/wrr.12245. Epub 2015 Feb 13.
Results Reference
background
PubMed Identifier
27119542
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A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

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