Venous Leg Ulcers
Conditions
Keywords
Venous leg ulcer, Ulcer, Venous stasis, Compression
Brief summary
Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers
Interventions
BIOLOGICALHP802-247
260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
Sponsors
Healthpoint
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide informed consent * Age ≥ 18 years and of either sex * Willing to comply with protocol instructions, including allowing all study assessments * Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm * Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence * Arterial supply adequacy confirmed * Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone * Target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months). * Acceptable state of health and nutrition
Exclusion criteria
* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B or any other component of HP802-247,or known sensitivity to Iodine * Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication * Therapy with another investigational agent within thirty (30) days of Screening, or during the study, or any participation in a previous HP802-247 trial * A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic) * Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit * Refusal of or inability to tolerate compression therapy * Therapy of the target ulcer with Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit * Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit * Current therapy with systemic antibiotics * Current systemic therapy with cytotoxic drugs * Current therapy with chronic (\> 10 days) oral corticosteroids * Current therapy with TNFα inhibitors * History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 | Wound fluid samples were to be collected one week after the initial dose of HP802-247. | The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point \[i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3\]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3). |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at a single US investigation site, between July 14,2014 and November 2, 2014.
Pre-assignment details
Subjects entered a 2-week run-in; subjects whose wound radius decreased by \< 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization. HP802-247
Participants by arm
| Arm | Count |
|---|---|
| HP802-247 HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study Termination | 1 |
Baseline characteristics
| Characteristic | HP802-247 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point \[i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3\]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).
Time frame: Wound fluid samples were to be collected one week after the initial dose of HP802-247.
Population: Due to the failure of HP802-247-09-029 to show superiority over its vehicle in study 802-247-09-029, this study was terminated after enrollment of one of the proposed 25 subjects. No data was collected.