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

Summary

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

Eligibility

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 \[defined as amenorrhea for at least 1 year and serum follicle stimulating hormone (FSH) level \>40 IU/L\], 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.

   1. 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.
   2. 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.
   3. Intrauterine device
   4. Vasectomized Partner (for at least 6 months)
   5. 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).
3. Negative pregnancy test for all subjects of childbearing potential
4. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \>4 weeks duration.
5. No visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
6. Subjects' wound size is minimum of 2 cm2 and maximum of 24cm2
7. If the subject has more than one eligible wound the largest wound will be selected (the index wound)
8. Subject is able and willing to follow the protocol requirements
9. Subject has signed informed consent.

Exclusion Criteria:

1. Inability to adhere to the study protocol or study visit schedule
2. Pregnancy
3. Child-bearing potential without appropriate contraception
4. Lactation
5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
6. 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)
7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
8. Known contraindications to the use of either IP1 or IP2
9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics.

Conditions4

Locations7 sites

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