Venous Leg Ulcer
Conditions
Keywords
venous stasis ulcer, wound, chronic venous insufficiency
Brief summary
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
Detailed description
Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before being randomly assigned to either treatment using a dual action pneumatic compression device or continued multi-layer bandaging for up to 16 weeks. Participants will be seen in clinic for treatment and evaluation of symptoms and quality of life.
Interventions
Dual action pneumatic compression device used to treat chronic VLUs.
DEVICEMulti-Layer Bandaging
Multi-layer bandaging used to treated chronic VLUs
Sponsors
Tactile Medical
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
* Subject must be ≥ 18 years of age or legal age at the time of enrollment. * Chronic venous insufficiency confirmed by ultrasound within previous 12 months or prior to randomization: if subject had bilateral CVI, the limb that possessed the largest ulcer meeting study criteria was used as the study treatment limb for evaluation and documentation throughout the study. Non-study limbs received standard of care treatment as determined by the treating clinician. * Must have at least one of the following within the past six (6) months: Dorsalis Pedis (DP) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Posterior Tibial (PT) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Transcutaneous partial pressure oxygen (TcP02) \> 30mmHg; Great toe systolic pressure \> 40mmHg. * Active ulceration (CEAP classification of C6): VLU was defined by open skin lesion of the leg or foot that occurred in an area affected by venous hypertension. * Ulcer duration: Non healing VLU ≥ 1 month but not greater than 24 months. * Ulcer size ≥ 2cm² ≤ 50cm²: if there were multiple ulcers on the study limb, the largest ulcer was used as the study treatment ulcer for evaluation and documentation throughout the study. If two ulcers were separated by no more than one centimeter of normal skin, their areas were added together for study purposes. * Three or fewer separate full thickness ulcers on the study limb: sum of the ulcer areas on the study limb must be ≤ 50 cm². * Leg circumferences within the following range: Ankle - 12 to 44cm; Calf - 22 to 60cm; Below knee - 22 to 68cm. * Able and willing to provide informed consent prior to study participation.
Exclusion criteria
* Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone. * Target ulcer was of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy). * Treatment of the target ulcer with living cellular therapy within 30 days of the time of projected randomization. * Endovenous ablation or other venous surgery within two weeks of enrollment: venous ultrasound must be completed after procedure to determine whether there is still venous insufficiency at the time of enrollment. * History of skin sensitivity to any of the components of ACT, multi-layer bandages of compression garments. * History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last three (3) months. * Acute thrombophlebitis within the last six (6) weeks. * History of pulmonary edema or decompensated congestive heart failure within six (6) weeks of screening. * Currently has an active infection of the skin on the target limb such as cellulitis requiring antibiotics. * History of target limb cancer within the last 2 years with the exception of treated non-melanoma skin cancer unless ulcer biopsy performed at screening is negative for neoplasia. * Active cancer receiving chemotherapy and/or radiation therapy. * Poorly controlled diabetes with an HbA1c value of \> 12% within the past three (3) months. * Changes to medications that affected edema within the last 30 days prior to enrollment (e.g., diuretics, calcium channel blockers of the dihyropyridine class, pioglitazone, cox-1 inhibitors, pregabalin, and gabapentin, diltiazem, or fluctuating doses of systemic steroids). * Use of systemic corticosteroids requiring daily administration at doses greater than 5mg of Prednisone per day or equivalent for greater than 2 weeks: low dose steroid administration (Prednisone up to 5 mg per day or equivalent) was allowable for an unlimited period of time. Topical steroid administration to peri-ulcer area or other skin was allowable but could not be applied to the ulcer itself. * Currently pregnant or trying to become pregnant. * Inability or unwillingness to participate in all aspects of study protocol. * Exhibited any condition which, according to the Investigator, justified the subject's exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable. * Currently participating in another clinical trial. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of VLU Area Reduction | Changes from Baseline to 16 weeks | Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Quality of Life | Changes from Baseline to 16 weeks | The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present. All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life). In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively. |
| Outpatient Costs | Changes from Baseline to 16 weeks | Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject. |
Countries
United States
Participant flow
Pre-assignment details
All subjects participated in a two week run-in phase. The treatment included MLB which was worn 24 hours a day except during clinic visits. The run-in phase was intended to assess the subject's initial response to standard of care treatment using MLB before receiving treatment with the investigational device.
Participants by arm
| Arm | Count |
|---|---|
| Dual Action Pneumatic Compression Device ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
Dual Action Pneumatic Compression Device: Dual action pneumatic compression device used to treat chronic VLUs. | 26 |
| Multi-layer Bandaging PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
Multi-Layer Bandaging: Multi-layer bandaging used to treated chronic VLUs | 30 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 5 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 0 |
Baseline characteristics
| Characteristic | Multi-layer Bandaging | Total | Dual Action Pneumatic Compression Device |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 10 | 63 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 40 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| 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 | 7 Participants | 11 Participants | 4 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 44 Participants | 21 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 23 Participants | 40 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 30 |
| other Total, other adverse events | 17 / 26 | 12 / 30 |
| serious Total, serious adverse events | 1 / 26 | 2 / 30 |
Outcome results
Primary
Percentage of VLU Area Reduction
Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
Time frame: Changes from Baseline to 16 weeks
Population: \*Per Protocol Population (MITT patients who were randomized, received treatment, and did not exit the study early).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Action Pneumatic Compression Device | Percentage of VLU Area Reduction | -83.8 percentage change | Standard Deviation 27.8 |
| Multi-layer Bandaging | Percentage of VLU Area Reduction | -70.5 percentage change | Standard Deviation 52 |
Secondary
Outpatient Costs
Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
Time frame: Changes from Baseline to 16 weeks
Population: Per Protocol Population (Patients randomized who received treatment and had baseline and end of study measures).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Action Pneumatic Compression Device | Outpatient Costs | 6748 Dollars | Standard Deviation 1308 |
| Multi-layer Bandaging | Outpatient Costs | 8925 Dollars | Standard Deviation 2176 |
Secondary
Patient-Reported Quality of Life
The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present. All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life). In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time frame: Changes from Baseline to 16 weeks
Population: Per Protocol Population (Patients randomized who received treatment and had both Baseline and end of study measures).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dual Action Pneumatic Compression Device | Patient-Reported Quality of Life | -10.3 Change in total score | Standard Deviation 15.4 |
| Multi-layer Bandaging | Patient-Reported Quality of Life | -1.7 Change in total score | Standard Deviation 11.2 |