Venous Leg Ulcers
Conditions
Keywords
VLU, Non- Healing Venous Leg Ulcers, Chronic Venous Leg Ulcers, Venous Leg Ulcers
Brief summary
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.
Interventions
OTHERNuShield®
NuShield® is a dehydrated placental allograft
Sponsors
Organogenesis
Professional Education and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 18 years of age or older. 2. Index Ulcer must be of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test) 3. The index ulcer must have been present for a minimum of 4 weeks 4. The subject must have a study wound that falls within a specified size range 5. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the index ulcer. 6. Index ulcer is located on the leg, below the knee and at or above the malleoli. 7. Partial or full-thickness index ulcer extending into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule. 8. The subject must be willing and able to participate, understand, and sign the IRB approved informed consent process prior to any study procedures. 9. Subjects agree to be compliant with all study requirements, including weekly study visits. 10. Females of childbearing potential must use acceptable methods of contraception (birth control pills, barriers, or abstinence) for at least one month prior to randomization and for the duration of study participation. Males must be willing to use acceptable methods of birth control (barriers or abstinence) from randomization through study participation. 11. Adequate circulation to the affected limb as documented by any of the following methods performed within 3 months prior to the first screening visit: 1. TCOM \> 30 mmHg 2. ABI \> 0.75 3. SPP \> 30mmHg 4. As an alternative, Arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle on the extremity the index ulcer is located. 12. Subject failed to adequately respond to conventional therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects that obtain complete closure | 16 weeks | The proportion of subjects that obtain complete closure. Complete closure is defined as full epithelialization of the wound with the absence of drainage and infection as well as visible epithelium on the wound surface. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects that obtain complete closure on or before 12 weeks of treatment | 12 weeks | The proportion of subjects that obtain complete closure on or before 12 weeks of treatment. Complete closure is defined as full epithelialization of the wound with the absence of drainage and infection as well as visible epithelium on the wound surface |
| Time to achieve complete wound closure of the index ulcer | 16 weeks | Number of weeks to achieve complete wound closure |
| Percentage wound area reduction | 16 weeks | Percentage change from baseline wound area to final wound area |
Countries
United States
Contacts
CONTACTAlex Erb
CONTACTMeghan Byrd
STUDY_DIRECTORMaribel Riesco
Organogenesis
Outcome results
None listed