NCT07046767 · Capsicure, LLC
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
(CAMP RWE)
What this study is about
CAMP RWE Trial: A conducted at multiple hospitals hybrid platform trial comparing the effects of a forward-looking group of participants treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched reviewing past data control group of participants of patients with hard-to-heal DFUs and VLUs
View original scientific description
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female 18 years of age and older
- 2\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \>4 weeks duration and 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 25cm2
- 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
Exclusion criteria
- Inability to adhere to the study protocol or study visit schedule
- Child-bearing potential without appropriate contraception
- 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 amniotic tissue grafts
- The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics
Where
- Oxnard, California
- Coral Gables, Florida
- Miami, Florida
- Indianapolis, Indiana
- St Louis, Missouri
- Syosset, New York
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 22, 2025 · Source of record for eligibility and locations