CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs

Recruiting N/A Interventional Study
Wound, Foot Diabetic Foot Ulcer (DFU) Venus Leg Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
147 (estimated)
Sponsor
Capsicure, LLC · Research network
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About This Trial

CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female 18 years of age and older 2. If a female is not currently pregnant or breastfeeding nor plans to become pregnant during the study and is either not of childbearing potential (defined as: postmenopausal \[defined as amenorrhea for at least 1 year and serum folli…
Contacts

Marissa Docter, RN, BSN, MD

512-571-2966

mdocter@capsicure.com

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