Amber Stormer
North Royalton, Ohio, 44133, United States
Location status: Recruiting
NCT Number: NCT07665268
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
North Royalton, Ohio, 44133, United States
Location status: Recruiting
This study is a multi-center, prospective, modified platform trial consisting of 2,000 subjects from up to Up to 75 providers at up to 25 investigational sites. The subjects are randomized to receive 1 of 5 treatments, either with Activate™ Matrix (CAMP-1) and SOC; AmnioDefend™ FT Matrix (CAMP-2) and SOC; Palisade™ Matrix (CAMP-3) and SOC; Sentry™ SL Matrix (CAMP-4) and SOC; Shelter™ DM Matrix (CAMP-5) and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of the five CAMPs + SOC or matched controls until or up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional, for the purpose of changing only the secondary dressing
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive weekly applications of Activate™ Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Participants will receive weekly applications of AmnioDefend™ FT Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Participants will receive weekly applications of Palisade™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Participants will receive weekly applications of Sentry™ SL Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Participants will receive weekly applications of Shelter™ DM Matrix and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
Time frame: 0-20 Weeks
Determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design.
Time frame: 0-20 Weeks
Determine the between-arm difference in the time to closure over 20 weeks for CAMP plus SOC versus mSOC.
Time frame: 0-20 Weeks
Determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC.
Time frame: 0-20 Weeks
Determine the between-arm difference in pain for patients that present with a Visual Analog Scale score of greater than 4. The scale is a rage of 0-10, 0 being no pain and 10 being worst pain imaginable.
Time frame: 0-20 Weeks
Evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC.
Time frame: 0-20 Weeks
Evaluate the between-arm difference in the quality of life for subjects receiving CAMP plus SOC compared to SOC only using the Forgotten Wound Score (FWS) at treatment visits 1, 4, 8, 12, 16, and 20.
Time frame: 0-20 Weeks
To determine compliance with off-loading and the effect on wound closure.
Time frame: 0-20 Weeks
To determine the proportion of ulcers that close in patients 65 years or older for CAMP plus SOC versus mSOC.
Time frame: 0-20 Weeks
Selected sites only: to demonstrate durability of closure (rate of recurrence) of subjects with a closed ulcer.
Contact information is provided by the study sponsor or research team.
Amy Allen
CONTACT
Bennett Sarver
CONTACT
Sequence LifeScience, Inc.
Industry
Acronym: RESTORE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02280733
Arterial Occlusive Diseases, Arterial Ulcers
The Woodlands, Texas, United States
View Trial DetailsNCT06369688
Bed Sore, Decubitus Sore
View Trial DetailsNCT02535481
Pathologic Processes, Pathological Conditions, Signs and Symptoms
London, United Kingdom
View Trial DetailsNCT06674980
Cardiovascular Diseases, Diabetes Complications
Metairie, Louisiana, United States
View Trial Details