BridgeMD
New treatment option for Wound, Foot
Official title 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
ClinicalTrials.gov ID: NCT07701590
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on subject's...
- Total abstinence from sexual activities that can lead to pregnancy for at least 6 months prior to Screening/Randomization Visit. Abstinence is...
- Intrauterine device
You likely can't join 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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 people of childbearing potential
- people 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
- people' 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Coral Gables, Florida, United States
- Miami, Florida, United States
- Indianapolis, Indiana, United States
- St Louis, Missouri, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Coral Gables, Florida, United States; Miami, Florida, United States; Indianapolis, Indiana, United States; St Louis, Missouri, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.