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 now · Not applicable

Conditions studied: Wound, Foot, Diabetic Foot Ulcer (DFU), Venus Leg Ulcer

In brief

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

Key facts

Study ID

NCT07701590

Run by

Capsicure, LLC

People needed

147

Starts

2026-06-22

Expected to finish

2026-12-20

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 18 years of age and older
• 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 follicle stimulating hormone (FSH) level >40 IU/L], or surgically sterile [bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or tubal ligation at least 6 months prior to IP administration]), or is practicing one or more of the following medically acceptable methods of birth control throughout the study.
• Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on subject's usual menstrual cycle period) before Screening/Randomization Visit and must follow that product's package insert instructions including additional protection at times when hormonal contraceptive doses might be missed.
• Total abstinence from sexual activities that can lead to pregnancy for at least 6 months prior to Screening/Randomization Visit. Abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle.
• Intrauterine device
• Vasectomized Partner (for at least 6 months)
• Double-barrier method (condoms and clerical cap with spermicidal jellies or cream or condoms and diaphragm with spermicidal jellies or cream or condoms and contraceptive foam).
• Negative pregnancy test for all subjects of childbearing potential
• Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of >4 weeks duration.
• No visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
• Subjects' wound size is minimum of 2 cm2 and maximum of 24cm2
• If the subject has more than one eligible wound the largest wound will be selected (the index wound)
• Subject is able and willing to follow the protocol requirements
• Subject has signed informed consent.

You may not qualify if…

• Inability to adhere to the study protocol or study visit schedule
• Pregnancy
• Child-bearing potential without appropriate contraception
• Lactation
• Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
• Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
• The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
• Known contraindications to the use of either IP1 or IP2
• The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics.

Where it is running

• North Park Podiatry — San Diego, California, United States (enrolling)
• Solutions Medical Research — Coral Gables, Florida, United States (enrolling)
• NAR Medical and Research — Miami, Florida, United States (enrolling)
• Nova Medical Services - Research Division LLC — Miami, Florida, United States (enrolling)
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
• St. Louis Foot and Ankle, LLC — St Louis, Missouri, United States (enrolling)
• Hope Vascular and Podiatry — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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