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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT00971048
First received: August 27, 2009
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Diabetic Foot Ulcers
Pressure Ulcers
Device: HP828-101
Device: Hydrogel/Hydrocolloid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool. [ Time Frame: 22 - 29 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Participants With Wound Closure by Day 22. [ Time Frame: 22 days ] [ Designated as safety issue: No ]
  • Pain Assessed by a 100-mm VAS Scale. [ Time Frame: At every visit: Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: No ]
    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) [ Time Frame: At every visit: Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: No ]
    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.


Enrollment: 88
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HP828-101 Device: HP828-101
Topical test article applied once daily
Other Name: New device, no brand name identified-Code name is HP828-101
Active Comparator: Standard of Care
For DFU SoC is a hydrogel. For PU SoC is a hydrocolloid gel.
Device: Hydrogel/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
Other Names:
  • 3M Tegaderm Hydrogel for DFU
  • ConvaTec DuoDERM Hydroactive Gel for PU

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971048

Locations
United States, California
Trovare Clinical Research
Bakersfield, California, United States, 93311
Absolute Foot Care
Chula Vista, California, United States, 91910
Roy Kroeker
Fresno, California, United States, 93710
Innovative Medical Technologies
Los Angeles, California, United States, 90063
San Diego Research Center
San Diego, California, United States, 92103
United States, Florida
Foot and Ankle Associates of Florida
Altamonte Springs, Florida, United States, 32701
United States, Illinois
Weil Foot and Ankle Institute
Des Plaines, Illinois, United States, 60016
United States, Texas
Prigoff-Bowers LLP
Dallas, Texas, United States, 75224
Richard Galperin, DPM
Dallas, Texas, United States, 75224
Robert Wunderlich, DPM
San Antonio, Texas, United States, 78212
United States, Utah
Dixie Regional Wound Clinic
St. George, Utah, United States, 84770
Sponsors and Collaborators
Healthpoint
Investigators
Study Director: Innes Cargill, PhD Healthpoint, Ltd
  More Information

Publications:
Sussman C, Bates-Jensen B. Wound Care - A Collaborative Practice Manual for Health Professionals. 3rd Ed. Philadelphia: Lippincott Williams & Wilkins, 2006.

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00971048     History of Changes
Other Study ID Numbers: 828-101-09-013
Study First Received: August 27, 2009
Results First Received: October 9, 2013
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
pressure ulcers
PU
diabetic foot ulcers
DFU
Bates-Jensen Wound Assessment

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pressure Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014