Diabetic Foot Ulcers, Pressure Ulcers
Conditions
Keywords
pressure ulcers, PU, diabetic foot ulcers, DFU, Bates-Jensen Wound Assessment
Brief summary
To compare HP828-101 to standard of care for the management of partial or full thickness wounds
Detailed description
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.
Interventions
DEVICEHP828-101
Topical test article applied once daily
DEVICEHydrogel/Hydrocolloid
Hydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | 22 - 29 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Closure by Day 22. | 22 days | — |
| Pain Assessed by a 100-mm VAS Scale. | At every visit: Day 8, Day 15, Day 22, Day 29 | 100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain) |
| Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | At every visit: Day 8, Day 15, Day 22, Day 29 | 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. |
Countries
United States
Participant flow
Recruitment details
Adults 18 years of age and older who had a DFU or PU on the foot that was a partial or full thickness wound
Participants by arm
| Arm | Count |
|---|---|
| HP828-101 Treating DFU HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU) | 30 |
| Standard of Care Treating DFU For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel
Hydrogel for DFU(3M Tegaderm Hydrogel) | 33 |
| HP828-101 Treating PU HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU) | 12 |
| Standard of Care Treating PU For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel
Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU) | 13 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Standard of Care Treating DFU | HP828-101 Treating PU | HP828-101 Treating DFU | Standard of Care Treating PU | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 5 Participants | 12 Participants | 6 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 7 Participants | 18 Participants | 7 Participants | 49 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 10.4 | 61.3 years STANDARD_DEVIATION 12.6 | 61.5 years STANDARD_DEVIATION 13.5 | 64.1 years STANDARD_DEVIATION 17 | 62.6 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United States | 33 participants | 12 participants | 30 participants | 13 participants | 88 participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 11 Participants | 5 Participants | 30 Participants |
| Sex: Female, Male Male | 23 Participants | 8 Participants | 19 Participants | 8 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 33 | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 2 / 30 | 0 / 33 | 0 / 12 | 1 / 13 |
Outcome results
Primary
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.
Time frame: 22 - 29 days
Population: Intent-to-Treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HP828-101 Treating DFU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 22 | 20.28 units on a scale | Standard Error 0.89 |
| HP828-101 Treating DFU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 29 | 20.12 units on a scale | Standard Error 0.98 |
| Standard of Care Treating DFU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 29 | 18.71 units on a scale | Standard Error 0.93 |
| Standard of Care Treating DFU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 22 | 21.38 units on a scale | Standard Error 0.85 |
| HP828-101 Treating PU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 22 | 20.94 units on a scale | Standard Error 1.63 |
| HP828-101 Treating PU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 29 | 19.78 units on a scale | Standard Error 1.67 |
| Standard of Care Treating PU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 22 | 20.59 units on a scale | Standard Error 1.57 |
| Standard of Care Treating PU | Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. | Day 29 | 17.28 units on a scale | Standard Error 1.61 |
Secondary
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.
Time frame: At every visit: Day 8, Day 15, Day 22, Day 29
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HP828-101 Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 8 | 1.94 BWAT-m Exudate Score | Standard Error 0.14 |
| HP828-101 Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 15 | 1.78 BWAT-m Exudate Score | Standard Error 0.14 |
| HP828-101 Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 22 | 1.76 BWAT-m Exudate Score | Standard Error 0.17 |
| HP828-101 Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 29 | 1.69 BWAT-m Exudate Score | Standard Error 0.14 |
| Standard of Care Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 15 | 1.88 BWAT-m Exudate Score | Standard Error 0.13 |
| Standard of Care Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 22 | 1.77 BWAT-m Exudate Score | Standard Error 0.16 |
| Standard of Care Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 29 | 1.51 BWAT-m Exudate Score | Standard Error 0.12 |
| Standard of Care Treating DFU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 8 | 1.90 BWAT-m Exudate Score | Standard Error 0.14 |
| HP828-101 Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 22 | 1.89 BWAT-m Exudate Score | Standard Error 0.32 |
| HP828-101 Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 15 | 1.80 BWAT-m Exudate Score | Standard Error 0.25 |
| HP828-101 Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 29 | 1.98 BWAT-m Exudate Score | Standard Error 0.37 |
| HP828-101 Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 8 | 1.78 BWAT-m Exudate Score | Standard Error 0.2 |
| Standard of Care Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 29 | 2.02 BWAT-m Exudate Score | Standard Error 0.41 |
| Standard of Care Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 15 | 1.95 BWAT-m Exudate Score | Standard Error 0.24 |
| Standard of Care Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 8 | 2.43 BWAT-m Exudate Score | Standard Error 0.19 |
| Standard of Care Treating PU | Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT) | Day 22 | 2.24 BWAT-m Exudate Score | Standard Error 0.34 |
Secondary
Number of Participants With Wound Closure by Day 22.
Time frame: 22 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HP828-101 Treating DFU | Number of Participants With Wound Closure by Day 22. | 5 Subjects |
| Standard of Care Treating DFU | Number of Participants With Wound Closure by Day 22. | 1 Subjects |
| HP828-101 Treating PU | Number of Participants With Wound Closure by Day 22. | 1 Subjects |
| Standard of Care Treating PU | Number of Participants With Wound Closure by Day 22. | 3 Subjects |
Secondary
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)
Time frame: At every visit: Day 8, Day 15, Day 22, Day 29
Population: Intent-to-Treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| HP828-101 Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 8 | 8.92 VAS Pain Scores | Standard Error 1.84 |
| HP828-101 Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 15 | 8.09 VAS Pain Scores | Standard Error 2.18 |
| HP828-101 Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 22 | 9.57 VAS Pain Scores | Standard Error 2.9 |
| HP828-101 Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 29 | 7.16 VAS Pain Scores | Standard Error 2.41 |
| Standard of Care Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 15 | 3.21 VAS Pain Scores | Standard Error 2.07 |
| Standard of Care Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 22 | 3.6 VAS Pain Scores | Standard Error 2.76 |
| Standard of Care Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 29 | 1.53 VAS Pain Scores | Standard Error 2.3 |
| Standard of Care Treating DFU | Pain Assessed by a 100-mm VAS Scale. | Day 8 | 4.85 VAS Pain Scores | Standard Error 1.75 |
| HP828-101 Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 22 | 3.66 VAS Pain Scores | Standard Error 3.5 |
| HP828-101 Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 15 | 3.49 VAS Pain Scores | Standard Error 2.95 |
| HP828-101 Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 29 | 4.33 VAS Pain Scores | Standard Error 2.36 |
| HP828-101 Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 8 | 4.76 VAS Pain Scores | Standard Error 1.21 |
| Standard of Care Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 29 | 8.70 VAS Pain Scores | Standard Error 2.26 |
| Standard of Care Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 15 | 8.85 VAS Pain Scores | Standard Error 2.83 |
| Standard of Care Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 8 | 6.99 VAS Pain Scores | Standard Error 1.16 |
| Standard of Care Treating PU | Pain Assessed by a 100-mm VAS Scale. | Day 22 | 6.63 VAS Pain Scores | Standard Error 3.36 |