Varicose Ulcer, Venous Insufficiency
Conditions
Brief summary
The purpose of this study is to evaluate and compare healing characteristics, reduction in the size of the wound and to measure complete healing of the wound following the application of a biologic product dressing instead of the alginate dressing along with standard debridement and compression therapy versus the standard of care treatment for VLUs. The biologic product that will be used in this study is called AmnioExCel™.
Detailed description
Approximately 40 participants will be enrolled in this study at the Greenville Health System. Participation is anticipated to last up to 15 weeks and will include a two week screening period, randomization (Visit 1) and office visits at the study doctor's office once every week for up to 12 weeks (Visit 2 - Visit 12). All participants will receive the standard of care wound treatment during the 2 week screening period. The treatment plan outlined in treatment group 1 or treatment group 2 will be followed after randomization. Participants will be randomly assigned (like flipping a coin) into one of two treatment groups. There is an equal chance to be enrolled into either of the two treatment groups. Neither the participant nor the study doctor can control the group assignment. Treatment Group 1: participants will receive the standard of care treatment including the use of a multi-layer compression wrap for their VLU. Treatment Group 2: participants will receive the application of the biologic product AmnioExCel™ dressing instead of the application of an alginate dressing in addition to standard debridement and the use of a multi-layer compression wrap for their VLU. If participants have more than one VLU, only one will be enrolled in the study and will receive the application of the AmnioExCel™ dressing. The remaining VLUs will receive the application of the alginate dressing. AmnioExCel™ is a human cellular and tissue based product that is registered with the United States Food and Drug Administration (FDA). It is intended for use as a wound covering and is made of a dehydrated human amniotic membrane (innermost layer of the placenta) that was obtained from donated human placenta. The use of AmnioExCel™ specifically for this study is not considered as standard of care.
Interventions
BIOLOGICALAmnioExCel dressing and compression therapy
Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers
PROCEDURESOC alginate dressing and compression therapy
Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing
Sponsors
Clemson University
BioDlogics
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, 18 years or older 2. At least one VLU with a total surface area between 2 cm2 and 100 cm2 3. VLU present for at least 1 month 4. Presence of a VLU extending through the full thickness of the skin but not down to muscle, tendons, or bones 5. Ulcer has a clean, granulating base with minimal adherent slough 6. VLU has been treated with compression therapy for at least 14 days 7. The study VLU has \< 30% area reduction with SOC treatment for the duration ≥ 2 weeks screening period 8. At least one of the following within the last 6 months: * An Ankle-Brachial Index (ABI) of \> 0.75 * Dorsalis Pedis (DP) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb * Posterior Tibial (PT) systolic pressure ≥ 80 mm Hg for diabetic patients or ≥ 60 mm Hg for non-diabetic patients on study limb * Great toe systolic pressure ≥ 40 mm Hg 9. Willingness to comply with the protocol, attend all follow-up visits, complete all protocol related assessments and provide informed consent
Exclusion criteria
1. Presence of an active infection of the skin on the target limb such as cellulitis requiring antibiotics 2. Ulcer caused by a medical condition other than venous insufficiency 3. Ulcer suspicious for cancer 4. Known history of AIDS or HIV 5. Previously treated with tissue engineered materials (e.g., Apligraft, Dermagraft or EpiFix) or other scaffold materials (e.g., Oasis or Puraply) in the past three months on the target VLU. 6. Receipt of a biologic agent, growth factor or skin substitute within the prior 30 days 7. Known sensitivity to ethanol 8. Uncontrolled diabetes mellitus with a HgBA1c of \> 10% within the past 3 months 9. Rheumatoid arthritis 10. Significant lower extremity arterial occlusive disease that would preclude the use of compression therapy 11. NYHA Class III and IV congestive heart failure (CHF) 12. Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus 13. Currently receiving radiation therapy or chemotherapy 14. Receiving immune modulators 15. Currently pregnant or trying to get pregnant 16. Breast feeding 17. Not willing to provide written informed consent or remain in compliance with the study protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wound Area | 12 weeks | Average percent change in wound area, computed with respect to wound area at time 0. Wound area assessed at baseline (time 0) and then weekly; change from baseline to 12 weeks reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Pain Score | 12 weeks | Pain assessed at weekly visits using the Wong-Baker FACES (Family And Caregiver Education & Support) Pain Scale. Change from baseline to 12 weeks reported. Self-report measure of pain from 0 to 10, with higher values representing a worse outcome. 0 = No hurt and 10 = Hurts Worst |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SOC Alginate Dressing SOC absorptive alginate primary dressing in conjunction with a class II multi-layer compression wrap and standard debridement
SOC alginate dressing and compression therapy: Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing | 1 |
| AmnioExCel Dressing AmnioExCel dressing in conjunction with a class II multilayer compression wrap and standard debridement
AmnioExCel dressing and compression therapy: Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | AmnioExCel Dressing | Total | SOC Alginate Dressing |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 70 years | 61 years STANDARD_DEVIATION 0 | 52 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1 | 1 / 1 |
| other Total, other adverse events | 0 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Change in Wound Area
Average percent change in wound area, computed with respect to wound area at time 0. Wound area assessed at baseline (time 0) and then weekly; change from baseline to 12 weeks reported.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC Alginate Dressing | Change in Wound Area | 2.94 percentage of change |
| AmnioExCel Dressing | Change in Wound Area | -31.58 percentage of change |
Secondary
Change in Patient Pain Score
Pain assessed at weekly visits using the Wong-Baker FACES (Family And Caregiver Education & Support) Pain Scale. Change from baseline to 12 weeks reported. Self-report measure of pain from 0 to 10, with higher values representing a worse outcome. 0 = No hurt and 10 = Hurts Worst
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC Alginate Dressing | Change in Patient Pain Score | -100 percent of change |
| AmnioExCel Dressing | Change in Patient Pain Score | -100 percent of change |