Study Summary
This trial will monitor the progress of wounds in people with venous or diabetic ulcers while they use Mepilex Up dressing to see how it helps them heal over time.
Eligible Conditions
- Venous Leg Ulcer
- wound
- Skin Wound
- Wound Leg
- Foot Wound
- Diabetic Foot Ulcers
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 28 Secondary · Reporting Duration: A maximum total treatment period of 44 days or until healed, whichever occurs first.
Day 44
Compliance to offloading
Compliance with compression
Compression removed/changed/applied
Evaluation of Wound Quality of Life (QoL) (PRO)
For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO)
For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO)
Offloading Use/Type
Edema
Primary dressing's ability to be comfortable to wear (PRO)
Status of dressing during a routine dressing change or complication
Technical Performance (Investigator/designee's evaluation)
Injury wounds
Pain
Day 44
Change in exudate amount over time
Change in exudate nature over time
Change in granulation tissue over time
Change in maceration over time
Skin
Change in sloughy tissue over time
Cleansing performed
Debridement
Evaluation of all reported adverse events and device deficiencies
Injury wounds
Percentage wound area reduction over time
Percentage wound volume reduction over time (DFUs only)
Wear time (days)
Pain
Injury wounds
Injury wounds
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Supportive Care with Mepilex Up
1 of 1
Experimental Treatment
68 Total Participants · 1 Treatment Group
Primary Treatment: Supportive Care with Mepilex Up · No Placebo Group · N/A
Supportive Care with Mepilex Up
Device
Experimental Group · 1 Intervention: Mepilex Up · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: a maximum total treatment period of 44 days or until healed, whichever occurs first.
Who is running the clinical trial?
Molnlycke Health Care ABLead Sponsor
53 Previous Clinical Trials
14,266 Total Patients Enrolled
Hadar Lev-Tov, MD, MASPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
129 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- 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.
- 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.
- European Wound Management Association (EWMA). Position document: Wound bed preparation in practice. London: MEP Ltd. 2004.
- González de la Torre H, Quintana-Lorenzo ML, Perdomo-Pérez E, Verdú 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.
- World Union of Wound Healing Societies (WUWHS). Principles of best practice: Wound exudate and the role of dressings. A consensus document. 2019.
- 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.
- Hjermstad, Marianne Jensen, Peter M. Fayers, Dagny F. Haugen, Augusto Caraceni, Geoffrey W. Hanks, Jon H. Loge, Robin Fainsinger, Nina Aass, and Stein Kaasa. 2011. “Studies Comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for Assessment of Pain Intensity in Adults: A Systematic Literature Review”. Journal of Pain and Symptom Management. Elsevier BV. doi:10.1016/j.jpainsymman.2010.08.016.
- Fletcher J. Development of a new wound assessment form, Clinical practice development. Wounds UK. 2010;6(1).
- Chadwick P, McCardle J. Exudate management using a gelling fibre dressing. The Diabetic Foot Journal. 2015;18(1):43-8.
- Romanelli M, Vowden K, Weir D. Exudate Management Made Easy Wounds International 2010.
- Augustin, Matthias, Elena Conde Montero, Nicole Zander, Katrin Baade, Katharina Herberger, E. Sebastian Debus, Holger Diener, Thomas Neubert, and Christine Blome. 2017. “Validity and Feasibility of the Wound-qol Questionnaire on Health-related Quality of Life in Chronic Wounds”. Wound Repair and Regeneration. Wiley. doi:10.1111/wrr.12583.
- 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, 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2022. "A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05588583.
Frequently Asked Questions
What is the scale of this research investigation?
"Affirmative. According to clinicaltrials.gov, this research protocol is currently recruiting participants; it was posted on October 31st 2022 and revised on November 7th of the same year. The study has room for 68 enrollees between two sites." - Anonymous Online Contributor
Unverified Answer
Does this research currently have any room for new participants?
"As per the information available on clinicaltrials.gov, this research is currently recruiting individuals to take part in the trial. This study was publicly uploaded on October 31st 2022 and has since been revised on November 7th of that year." - Anonymous Online Contributor
Unverified Answer