Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

Study Overview
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Brief Summary
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To compare HP828-101 to standard of care for the management of partial or full thickness wounds

Detailed Description
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The primary objective is to compare HP828-101 to standard of care for the management of partial or full thickness wounds, evaluated using the Bates Jensen Wound Assessment Tool (BWAT). The secondary objectives are comparison of the proportion of subjects with wound closure by day 22, comparison of pain assessed using a visual analog scale (VAS), and evaluation of moist wound environment as per the BWAT.

Official Title
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Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

Conditions
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Diabetic Foot Ulcers, Pressure Ulcers

Intervention / Treatment
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* Device: HP828-101
* Device: Hydrogel/Hydrocolloid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart. For subjects that agree to have their wound photographed for the trial, a photo release consent form must be signed and documented as well. Age 18 years or older, of either sex, and of any race or skin type, provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments. Females, if of child-bearing potential, have a negative urine pregnancy test and agree to use acceptable contraception during the study. Adequate birth control methods are defined as: hormonal-topical, oral, implantable, or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner. Have a partial or full thickness PU on the foot or ankle or DFU of <= 6 months duration and between ≥1.0 and ≤ 12.0 cm² in area. Are willing to make all required study visits. Are willing to follow instructions, in the opinion of the Investigator. Have, within 12 weeks prior to randomization, a serum albumin level ≥ 2.0 g/dL (20 g/L); Alkaline phosphatase, AST, ALT, serum creatinine, and BUN levels < 3 x upper limit of normal; HbA1C ≤ 12%; and Hemoglobin >= 8 g/dL. The most recently obtained value must be evaluated against these criteria. Please refer to Appendix 18.1.5 Have arterial supply adequacy confirmed by an Ankle Brachial Index (ABI) >= 0.7 and ≤ 1.1 or if the ABI is > 1.1, either a TcPO2 >= 40 mmHg, as measured on the foot, or great toe pressure ≥ 50 mm/Hg, For ulcers that will require surgical debridement prior to enrollment, the wound must be expected to remain a partial thickness wound after debridement. Exclusion Criteria: Have a known hypersensitivity to any of the test articles or their components. Have received therapy with another investigational agent within thirty (30) days of Visit 1. Are pregnant or nursing. Have clinical evidence of bacterial or fungal infection of the wound per visual/clinical assessment. Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic malignancy. Have had documented osteomyelitis on the target ulcer leg within 6 months preceding the screening visit. Have severe edema of the target ulcer leg. If being treated with Xenaderm, must stop treatment prior to enrolling in the study. Have received treatment with glucocorticoids for > 10 consecutive days within 6 months prior to the start of the study. Have received chemotherapy or radiation therapy within the past 5 years. Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit (e.g., Apligraf®). Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit. Current therapy with systemic or topical antibiotics or systemic therapy with cytotoxic drugs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP828-101<br> | Device: HP828-101<br>* Topical test article applied once daily<br>* Other names: New device, no brand name identified-Code name is HP828-101;|
| Active Comparator: Standard of Care<br>For DFU SoC is a hydrogel. For PU SoC is a hydrocolloid gel. | Device: Hydrogel/Hydrocolloid<br>* Hydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily<br>* Other names: ConvaTec DuoDERM Hydroactive Gel for PU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst. | 22 - 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Closure by Day 22. |  | 22 days | 
| Pain Assessed by a 100-mm VAS Scale. | 100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain) | At every visit: Day 8, Day 15, Day 22, Day 29 | 
| Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst. | At every visit: Day 8, Day 15, Day 22, Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure ulcers, PU, diabetic foot ulcers, DFU, Bates-Jensen Wound Assessment