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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer; Wounds; Wound of Skin; Wound Leg
• Intervention / Treatment: Device: ALLEVYN Non-Adhesive

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janet Kandrevas, MD, MS; Phone Number: 734-358-2174; Email: janet.kandrevas@molnlycke.com
• Study Contact Backup: Name: Andrea Picchietti, MS, CCRA; Phone Number: 260-258-3879; Email: andrea.picchietti@molnlycke.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Not yet recruiting
      • Center for Clinical Trials, Inc.
      • Principal Investigator: Alexander Reyzelman, DPO
      • Contact: Gayana Sarkisova, CCRC; Phone Number: 104 800-363-1063; Email: gayana@ccr-trials.com
  • Florida
    • Miami, Florida, United States, 33125
      • Recruiting
      • University of Miami
      • Contact: Aliette Espinosa; Phone Number: 305-689-3376; Email: a.espinosa2@med.miami.edu
      • Principal Investigator: Hadar Lev-Tov, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15222
      • Recruiting
      • Serena Group Research Institute
      • Contact: Laura Serena; Phone Number: 412-335-0764; Email: lserena@serenagroups.com
      • Principal Investigator: Thomas Serena, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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 DIPLO01 study
• Use of wound fillers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive Care with Non-Bordered Foam Dressing; All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.

Device: 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 contact layer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound progress of the total effect of treatment using ALLEVYN Non-Adhesive	Wound progress is the total effect of treatment using ALLEVYN Non-Adhesive 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.	From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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%.	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	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%.	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	Exudate amount will be captured as a subjective measure from the investigator/designee and assessed as none, scant, small, moderate, or large.	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	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.	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	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.	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	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.	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)	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.	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)	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.	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)	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.	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	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.	A maximum total treatment period of 44 days or until healed, whichever occurs first.
Primary dressing's ability to be comfortable to wear (PRO)	Subjects will be asked to rate the dressing's degree of comfort using a 4-item scale of very poor, poor, good, or very good.	A maximum total treatment period of 44 days or until healed, whichever occurs first.
Dressing's ability to be comfortable to wear with compression (PRO)	Subjects will be asked to rate the dressing's degree of comfort while wearing with compression using a 4-item scale of very poor, poor, good, or very good.	A maximum total treatment period of 44 days or until healed, whichever occurs first.
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.	A maximum total treatment period of 44 days or until healed, whichever occurs first.
Technical Performance (Investigator/designee's evaluation)	Several questions will be asked to evaluate the technical performance properties of the primary dressing. 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.	A maximum total treatment period of 44 days or until healed, whichever occurs first.
Status of dressing during a routine dressing change or complication	The status of the primary dressing 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.	A maximum total treatment period of 44 days or until healed, whichever occurs first.
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)	A maximum total treatment period of 44 days or until healed, whichever occurs first.
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	A maximum total treatment period of 44 days or until healed, whichever occurs first.
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).	A maximum total treatment period of 44 days or until healed, whichever occurs first.
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	From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
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)	From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.
Cleansing performed	The following cleansing details will be recorded for each Subject at each visit: Cleansing performed (No/Yes); Type of cleansing agent used	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	If any reported adverse events or device deficiencies are reported, an evaluation will take place to determine root cause.	From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first.

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Hadar Lev-Tov, MD, MAS, University of Miami

Publications and helpful links

General Publications

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
• 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.
• 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.
• 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.
• 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.
• World Union of Wound Healing Societies (WUWHS). Principles of best practice: Wound exudate and the role of dressings. A consensus document. 2019.
• European Wound Management Association (EWMA). Position document: Wound bed preparation in practice. London: MEP Ltd. 2004.
• Romanelli M, Vowden K, Weir D. Exudate Management Made Easy Wounds International 2010.
• Walker M, Parsons D. Hydrofiber® technology: its role in exudate management. Wounds UK; 2010. p. 31-38.
• 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.
• 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.
• 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.
• ALLEVYN Non-Adhesive. Advanced Wound Management <www.smith-nephew.com>. Accessed 2022 Apr 23.
• 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.
• Augustin M, Conde Montero E, Zander N, Baade K, Herberger K, Debus ES, Diener H, Neubert T, Blome C. Validity and feasibility of the wound-QoL questionnaire on health-related quality of life in chronic wounds. Wound Repair Regen. 2017 Sep;25(5):852-857. doi: 10.1111/wrr.12583. Epub 2017 Nov 2.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Venous Leg Ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Wounds and Injuries; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: DIPLO NBF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes