Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04709419 |
| Other study ID # |
STU-2020-1386 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 27, 2022 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a prospective, multicenter, double-blind, 1:1 randomized clinical trial. The
purpose of this study is to demonstrate that the use of Celliant Socks increases tissue
oxygenation (via oxygen saturation, StO2) and incidence of wound closure in subjects with
diabetic foot ulcers. This study will use hyperspectral imaging and wound assessment to
measure these outcomes. The study will enroll 254 evaluable subjects total, 127 per arm to
meet the Primary Endpoint. Enrollment may continue up to twenty-five hundred (2500) evaluable
subjects total to meet the Key Secondary Endpoint of complete wound closure.
Description:
Screening and Enrollment
Patients who present to the investigator's institution (through clinic admission, direct
transfer from another facility, or through the emergency room) may be recruited to
participate in the study. No direct marketing for subject recruitment will be done.
Patients approached for study participation will be at least 22 years of age at the time of
consent, will undergo wound assessment, and meet all eligibility requirements. Those meeting
eligibility criteria for the study will have the study explained to them by the Investigator.
An Informed Consent Form will be provided to sign according to Section 11 prior to undergoing
any study procedures. Patients will be encouraged to ask questions of the investigators. It
will be made clear to the patient that not participating in the study will in no way
influence the treatment plan or the relationship with the physician.
Wound Selection
Only one wound per subject will be included in the study. Subjects with multiple wounds will
have each wound measured for volume. The wound with the largest volume meeting all
eligibility requirements will be chosen for inclusion in the study. The etiology of the
chosen wound, and if it is a new or recurring, will be documented.
Randomization and Blinding Procedure
Prior to study initiation, Active and Control samples will be prepared in sealed and labeled
as A or B, also randomization envelopes will be provided to the research staff and used to
obtain randomization assignment. Within each randomization envelope, there is an assignment
of A or B. After run-in evaluation, the subjects wound will be debrided and dressed with SOC.
At the end of the procedure, subjects who continue to meet all inclusion and no exclusion
criteria will be randomized in a 1:1 ratio to be treated with either Control or Celliant
therapies, stratified by wound size (greater than size of 4 cm2) and study center. Study
staff will use the randomization number labels and sock assignment of socks A or B contained
in the envelope. The number will become the subject ID. The research staff will note the
randomization number and the treatment assignment letter (A or B) on the CRF. The key,
indicating therapy assignments (Active or Control), will only be available to staff not
directly involved in the study until after the subject has completed study activities.
Visit Schedule
Study procedures for each phase of study are outlined below. In a later section, details on
each study procedure are described, including equipment designation.
Screening
1. Explain purpose and nature of the study and obtain signature on the informed consent
document.
2. Screen the subject against protocol inclusion and exclusion criteria, including all
pertinent tests
1. ABI and/toe pressure
2. Ulcer History, measurement, and classification
3. Urine Pregnancy test (if indicated)
Baseline (may be done as same day as screening procedures)
1. Obtain general medical history and demographic information and social history
2. Complete a physical examination, body weight, height, and vital signs, including
measurement of resting heart rate, respiratory rate, and blood pressure while seated.
3. Select the target ulcer
4. Obtain complete history pertinent to DFU disease including duration of the target ulcer,
previous and current treatment.
5. Perform debridement if indicated. Debridement is to be performed using curette,
scissors, scalpel, or forceps.
6. Perform standardized photography and measurement of the study wound (eKare or available
camera with ruler). Assess the post-debridement ulcer area (cm2), perimeter (cm), and
greatest depth (cm) using the inSight device (eKare, Fairfax, VA). These values are the
baseline measurements for assessing accelerated wound closure at the two-week run-in
visit.
7. Perform baseline SPP (note - this procedure does not need to be performed at baseline
visit and can be performed at any visit through Run-In week 2/Therapy initiation visit).
8. Perform baseline tcpO2 (note - this procedure does not need to be performed at baseline
visit and can be performed at any visit through Run-In week 2/Therapy initiation visit).
9. Perform baseline hyperspectral imaging assessment on the dorsal and plantar aspects of
the foot.
10. Perform neuropathy and pain assessment.
11. Obtain blood for hematology, blood chemistry, etc that were not covered in
inclusion/exclusion studies.
12. Subjects who do not meet eligibility and fail to qualify to enter the Run-in will be
deemed Screen failures and discharged, noting the reasons for disqualification.
13. Collect all relevant concomitant medication (antibiotics, antifungals and other
anti-infective therapies)
14. Wounds will be dressed SOC and offloaded per physician discretion.
15. Subjects who qualify to enter the run-in will be instructed to refrain from using
excluded medications and return to the office for Run-in Visit 2 within 7 (±1) days.
Run-In Procedures/Therapy Initiation
Week 1 Run-in:
1. Assess target ulcer.
2. Perform debridement if indicated. Debridement is to be performed using a curette,
scissors, scalpel, or forceps.
3. Perform standardized photography of the study wound.
4. Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm)
using the inSight device.
5. If wound size (ulcer area) increases/decreases by 30% or more, patient will be deemed a
screen failure and removed from the study.
6. If wound size (ulcer area) decreases by less than 30%, patient wound will be treated
with standard of care and return for run-in Week 2 Run-In within 7 (±1) days.
7. Perform hyperspectral imaging assessment on the dorsal and plantar aspects of the foot.
8. Perform pain assessment.
9. Collect all relevant concomitant medication (antibiotics, antifungals and other
anti-infective therapies)
10. Wounds will be dressed SOC and offloaded per physician discretion.
Week 2 Run-in/Therapy Initiation:
1. Assess target ulcer
2. Perform debridement if indicated. Debridement is to be performed using curette,
scissors, scalpel, or forceps.
3. Perform standardized photography of the study wound.
4. Assess the post-debridement ulcer area (cm2), perimeter (cm), and greatest depth (cm)
using the inSight device.
5. If wound size (ulcer area) increases/decreases by 30% or more, patient will be deemed a
screen failure and removed from the study.
6. If wound size (ulcer area) increases/decreases by less than 30%, patient wound will
enter the study and randomized to either the Celliant Active or Control treatment arm.
7. Perform hyperspectral imaging of the dorsal and plantar aspects of the foot
8. Perform pain assessment.
9. Collect all relevant concomitant medication
10. Wound will be dressed with SOC and either Celliant Active or Control Sock applied.
11. Wound will be offloaded.
12. Provide subject with any additional medical socks needed until the next visit. Instruct
the subject to change the socks if they become wet, soiled, or bloody and under any
conditions dictated by PI instructions.
Therapy/Treatment Phase
Study Visit 1-11:
1. Document study compliance information from the subject
1. Amount of time the sock was worn throughout the week
2. Was it worn during the day/night?
3. When/why the sock was changed.
4. Has the sock been on in the 3 hours leading up to the appointment?
2. Remove sock and dressing and immediately perform hyperspectral imaging of the dorsal and
plantar aspects of the foot if wound is active or closed.
3. Assess target ulcer (if wound has closed, document as such, perform steps 7 and 8 and
skip to Study Visit - Wound Closed).
4. Debridement is to be performed, if indicated, using curette, scissors, scalpel, or
forceps. If debridement is necessary at weekly visits, all therapy must be removed and
replaced post-debridement.
5. Perform standardized photography of the study wound.
6. Assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight
device - if the wound is deemed closed by the physician, skip to EOS visit.
7. Perform SPP and tcPO2 measurements at Visit 4 (maybe be taken instead at visit 5 or 6 if
subject has not been wearing their treatment sock leading up to the visit or misses this
visit).
8. Collect all relevant concomitant medication
9. Perform pain assessment.
10. Redress the wound with standard of care (if wound is still active) and apply Celliant
Active or Control Sock and apply offloading (if indicated).
11. Wound will be offloaded.
12. Provide subject with any additional medical socks needed until the next visit. Instruct
the subject to change the socks if they become wet, soiled, or bloody and under any
conditions dictated by PI instructions. Instruct the subject that they must wear the
sock at all times and that including the 3 hours leading up to the next study visit.
Study Visit - Wound Closed
1. The study wound is defined as closed when there is complete skin re-epithelialization
without drainage or dressing requirements confirmed by the evaluating physician at 2
consecutive study visits 2 weeks apart.
2. At this visit the subject will perform the EOS evaluation and enter the follow-up phase
of the study.
Study Visit 12/EOS
1. If the study wound closes prior to the 12-week study mark, subjects will perform EOS
visit at the time of wound closure. See Study Visit - Wound Closed.
2. A subject whose wound does not close completely by week 12 will exited from the study
after the week 12 wound evaluation.
3. Document study compliance information from the subject
1. Amount of time the sock was worn throughout the week
2. Was it worn during the day/night?
3. When/why the sock was changed.
4. Has the sock been on in the 3 hours leading up to the appointment?
4. Remove sock and dressing and immediately perform hyperspectral imaging of the dorsal and
plantar aspects of the foot if wound is active or closed.
5. Assess target ulcer (if wound has closed, document as such, perform steps 7-12 and skip
to Study Visit - Wound Closed).
6. Perform standardized photography of the study wound.
7. Assess the ulcer area (cm2), perimeter (cm), and greatest depth (cm) using the inSight
device.
8. Perform SPP if wound is active or closed.
9. Perform tcpO2 if wound is active or closed.
10. Perform pain assessment
11. Ask the subject if they thought they were in the active or control group
12. Administer DFS-SF
13. Collect all relevant concomitant medication
14. Redress the wound per physician-directed standard of care.
Study Visit Follow up
1. If the subject's wound closes within the 12-week treatment window, they will enter the
follow up phase of the study.
2. At 3 months post closure, wound evaluation will be performed as outlined below. This
followup visit will be in person. In the event that an in-person visit is not possible,
a telehealth visit may be performed and documented as such.:
a. Assess the study wound to determine that it remained closed b. If the study wound has
reoccurred i. record the date of reoccurrence ii. measure the size of dehiscence or
re-ulceration iii. exit the subject from the follow up phase c. Assess the study foot
for new sites of ulceration i. record the date of reoccurrence ii. measure the size of
dehiscence or re-ulceration iii. exit the subject from the follow up phase
