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BR-AC의 유무에 관계없이 표준 관리로 처리 된 비 치유 정맥 다리 궤양

2026년 11월 2일 업데이트: BioStem Technologies

BR-AC의 유무에 관계없이 표준 관리로 처리 된 비 치유 정맥 다리 궤양의 전향 적, 다기관, 무작위, 통제 된 시험

This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone.

This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus standard of care only in the treatment of venous leg ulcers. The eligibility criteria for this study will allow for enrollment of subjects with a VLU in the range of 2 cm^2 to 20 cm^2 in area. A lower size of 2 cm^2 was selected to exclude subjects who are likely to heal under compression therapy alone.

During the two-week run-in period, subjects who show a reduction in wound area predictive of achieving complete wound closure within 12 weeks under standardized care alone (i.e., compression therapy) will be excluded from the study. Eliminating these subjects will improve the estimated treatment effect. The criteria for duration, ≥ 4 weeks but ≤ 52 weeks, allows for the selection of those wounds that have demonstrated chronicity but may still have the potential to achieve wound closure.

The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for evaluating venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence, debridement, and compression therapy. Weekly subject visits will help monitor compliance in wound care and compression therapy, as well as to document when wound closureis achieved. The study will implement the use of an electronic imaging and measurement device (eKare inSight®) using a standardized protocol to ensure the measuring of the wound surface area is accurate, highly reproducible, and minimally variable.

There will also be a crossover treatment phase for those patients that were relegated to SOC only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AC product following the protocol and procedures set forth within this document.

A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow-up period will consist of a four-week follow-up with two visits at each two-week interval.

연구 유형

중재적

등록 (실제)

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

미국
- Alabama
  - Guntersville, Alabama, 미국, 35976
    - Site 17
- California
  - Castro Valley, California, 미국, 94546
    - Site 2b
  - Glendale, California, 미국, 91204
    - Site 19b
  - Oxnard, California, 미국, 93030
    - Site 36
  - Oxnard, California, 미국, 93036
    - Site 37
  - Palmdale, California, 미국, 93551
    - Site 19
  - San Francisco, California, 미국, 94115
    - Site 02
  - San Francisco, California, 미국, 94117
    - Site 2a
  - Sylmar, California, 미국, 91342
    - Site 04
  - Torrance, California, 미국, 90502
    - Site 30
  - Vista, California, 미국, 92081
    - Site 01
- Florida
  - Aventura, Florida, 미국, 33180
    - Site 34
  - Coral Gables, Florida, 미국, 33134
    - Site 27
  - Deerfield Beach, Florida, 미국, 33442
    - Site 20
  - Miami, Florida, 미국, 33126
    - Site 35
  - Miami, Florida, 미국, 33189
    - Site 31
- Illinois
  - O'Fallon, Illinois, 미국, 62269
    - Site 06
- Massachusetts
  - Boston, Massachusetts, 미국, 02118
    - Site 18
- Missouri
  - St Louis, Missouri, 미국, 63128
    - Site 32
- New York
  - Lake Success, New York, 미국, 11042
    - Site 16
- Texas
  - Corpus Christi, Texas, 미국, 78414
    - Site 38
  - Fort Worth, Texas, 미국, 76104
    - Site 03

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Patient has signed the informed consent form.
Male or female patient at least 18 years of age or older, as of the date of the screening visit.
Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
1. If the subject presents with > 1, but ≤ 3 VLU on the same leg, the largest ulcer will be selected as the target ulcer.
2. If the target ulcer is < 1cm from another VLU, the ulcers should be traced as a single target ulcer provided at least one of the ulcers is at least 2.0 cm2 in area and the total surface area of the VLUs is ≤ 20.0 cm2.
Target ulcer involves a full-thickness skin loss, but without exposure of tendon, muscle, or bone.
Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months).
Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence.

a. Availability of a complete report of a previous examination performed 12 months of screening will be acceptable, and this examination would not be required to be repeated.
Arterial supply adequacy confirmed by any one of the following:
1. Great toe pressure ≥ 50 mm/Hg
2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.80 ≤ 1.10
3. TcPO2 ≥ 40 mmHg from the foot
Willing to follow all instructions given by the Investigator, return for all visits, and adhere to compression protocols while on the study.

Exclusion Criteria:

A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
Acute Deep Vein Thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
Clinical evidence of ulcer bed infection, or infected hardware.
Documented history of osteomyelitis at the target ulcer location within six (6) months preceding the screening visit.
Refusal or inability to tolerate compression therapy.
Pregnant women.
Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
Hemoglobin A1c (HbA1c) level is > 12% (108 mmol/mol).
Current therapy with systemic antibiotics.
Current therapy with cytotoxic agents.
Current therapy with chronic (> 10 days) oral corticosteroids.
Current therapy with TNFα inhibitors other than Trental® (pentoxifylline).
Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
Has malignancy or history of cancer in the preceding 5 years other than non-melanoma skin cancer.
Currently on dialysis or planning to start dialysis.
Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
Therapy of the target ulcer with other birth tissue products, autologous skin graft, Apligraf®, or Dermagraft® within 30 days preceding the screening visit.
Therapy of the target ulcer with topical growth factors within thirty (30) days preceding the screening visit.
Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 하나의

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: BR-AC plus Standard Care All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as: Sharp debridement, Wound cleansing with a neutral, non-irritating and non-toxic solution, Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and The UrgoK2™ dual compression system providing around 40 mmHg. Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.	다른: BR-AC BR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization.
활성 비교기: Standard Care All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as: Sharp debridement, Wound cleansing with a neutral, non-irritating and non-toxic solution, Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and The UrgoK2™ dual compression system providing around 40 mmHg.	다른: Standard Care Standard Care is defined as: Sharp debridement, Wound cleansing with a neutral, non-irritating and non-toxic solution, Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and The UrgoK2™ dual compression system providing around 40 mmHg.

참가자 그룹 / 팔

개입 / 치료

실험적: BR-AC plus Standard Care

All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as:

Sharp debridement,
Wound cleansing with a neutral, non-irritating and non-toxic solution,
Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and
The UrgoK2™ dual compression system providing around 40 mmHg.

Using an appropriate size to cover the entire wound area, BR-AC should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.

다른: BR-AC

BR-AC is an amnion layer, intermediate layer, and chorion layer placental membrane processed together with no separation of the layers. BR-AC is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method, which, briefly includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C, and electron beam sterilization.

활성 비교기: Standard Care

All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as:

Sharp debridement,
Wound cleansing with a neutral, non-irritating and non-toxic solution,
Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and
The UrgoK2™ dual compression system providing around 40 mmHg.

다른: Standard Care

Standard Care is defined as:

Sharp debridement,
Wound cleansing with a neutral, non-irritating and non-toxic solution,
Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and
The UrgoK2™ dual compression system providing around 40 mmHg.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
To determine whether non-ischemic, non-infected VLUs treated with standard care plus BR-AC results in a higher probability of achieving complete wound closure compared to standard care alone. 기간: over the 12-week treatment period	Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization	over the 12-week treatment period

2차 결과 측정

결과 측정	측정값 설명	기간
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure 기간: at 12 weeks	Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization	at 12 weeks
To compare differences between treatment groups in percent change in wound area (cm2) 기간: at 12 weeks	Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization	at 12 weeks
To determine the total number of applications of BR-AC needed to achieve complete wound closure 기간: at 12 weeks	Percent change from baseline in wound volume (cm3) at 12-weeks post-randomization	at 12 weeks
To determine whether subjects that crossover and receive standard care plus BR-AC results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone 기간: over an additional 12 weeks	Time in days from Visit 18 to initial observation of wound closure (defined as 100% reepithelialization of the wound without drainage) over an additional 12 weeks (Visits 19-30), where healing has been confirmed at two visits two weeks apart	over an additional 12 weeks

기타 결과 측정

결과 측정	측정값 설명	기간
Number of participants that acquire clinical signs and symptoms of infections post-randomization 기간: over 12-weeks post-randomization	Differences in clinical signs and symptoms of infection from Visit 2 through end of study between the treatment groups	over 12-weeks post-randomization
Proportion of subjects experiencing adverse events, by treatment group 기간: over the 17-week study period	Spontaneously reported and elicited adverse events, coded in MedDRA	over the 17-week study period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

BioStem Technologies

수사관

연구 책임자: Bert Slade, MD, Independent

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 2월 14일

기본 완료 (실제)

2026년 8월 14일

연구 완료 (실제)

2026년 8월 14일

연구 등록 날짜

최초 제출

2025년 1월 22일

QC 기준을 충족하는 최초 제출

2025년 2월 5일

처음 게시됨 (실제)

2025년 2월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

BR-AC-VLU-101

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

BR-AC의 유무에 관계없이 표준 관리로 처리 된 비 치유 정맥 다리 궤양