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

NCT05608317 | Recruiting FDA Device

• 1 other identifier: DIPLO NBF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Wounds; Wound of Skin; Wound Leg; Venous Leg Ulcer

Keywords

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• 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.

• 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 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.

• 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.

Study Arms (1)

Supportive Care with Non-Bordered Foam Dressing

EXPERIMENTAL

All Subjects will use a non-bordered foam dressing as the absorbent primary dressing.

Device: ALLEVYN Non-Adhesive

Interventions

ALLEVYN Non-Adhesive DEVICE

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

Supportive Care with Non-Bordered Foam Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (3)

Center for Clinical Trials, Inc.

San Francisco, California, 94115, United States

NOT YET RECRUITING

University of Miami

Miami, Florida, 33125, United States

RECRUITING

Serena Group Research Institute

Pittsburgh, Pennsylvania, 15222, United States

RECRUITING

Related Publications (18)

• 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.

  PMID: 25486905 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• Chadwick P, McCardle J. Exudate management using a gelling fibre dressing. The Diabetic Foot Journal. 2015;18(1):43-8.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• World Union of Wound Healing Societies (WUWHS). Principles of best practice: Wound exudate and the role of dressings. A consensus document. 2019.

  BACKGROUND

• European Wound Management Association (EWMA). Position document: Wound bed preparation in practice. London: MEP Ltd. 2004.

  BACKGROUND

• Romanelli M, Vowden K, Weir D. Exudate Management Made Easy Wounds International 2010.

  BACKGROUND

• Walker M, Parsons D. Hydrofiber® technology: its role in exudate management. Wounds UK; 2010. p. 31-38.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• ALLEVYN Non-Adhesive. Advanced Wound Management <www.smith-nephew.com>. Accessed 2022 Apr 23.

  BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21621130 BACKGROUND

• 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.

  PMID: 29080332 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hadar Lev-Tov, MD, MAS

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Kandrevas, MD, MS

CONTACT

734-358-2174; janet.kandrevas@molnlycke.com

Andrea Picchietti, MS, CCRA

CONTACT

260-258-3879; andrea.picchietti@molnlycke.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The model is a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic venous leg ulcers over time for 6 weeks according to local standard of care.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: November 8, 2022
• Primary Completion: July 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)