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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers; Pressure Ulcers
• Intervention / Treatment: Device: HP828-101; Device: Hydrogel/Hydrocolloid

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HP828-101	Device: HP828-101; Topical test article applied once daily; Other Names: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Healthpoint
• Investigators: Study Director: Innes Cargill, PhD, Healthpoint, Ltd

Publications and helpful links

General Publications

• HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
• Winter GD. Formation of the scab and the rate of epithelisation of superficial wounds in the skin of the young domestic pig. 1962. J Wound Care. 1995 Sep;4(8):366-7; discussion 368-71. No abstract available.
• Ovington LG. The evolution of wound management: ancient origins and advances of the past 20 years. Home Healthc Nurse. 2002 Oct;20(10):652-6. doi: 10.1097/00004045-200210000-00009.
• Andersen CA, Roukis TS. The diabetic foot. Surg Clin North Am. 2007 Oct;87(5):1149-77, x. doi: 10.1016/j.suc.2007.08.001.
• Frykberg RG. Epidemiology of the diabetic foot: ulcerations and amputations. Adv Wound Care. 1999 Apr;12(3):139-41. No abstract available.
• Sussman C, Bates-Jensen B. Wound Care - A Collaborative Practice Manual for Health Professionals. 3rd Ed. Philadelphia: Lippincott Williams & Wilkins, 2006.
• Hess CT. Wound Care. 5th Ed ed. Philadelphia: Lippincott Williams & Wilkins, 2005.
• Steed DL, Attinger C, Colaizzi T, Crossland M, Franz M, Harkless L, Johnson A, Moosa H, Robson M, Serena T, Sheehan P, Veves A, Wiersma-Bryant L. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):680-92. doi: 10.1111/j.1524-475X.2006.00176.x. No abstract available.
• Agren MS. An amorphous hydrogel enhances epithelialisation of wounds. Acta Derm Venereol. 1998 Mar;78(2):119-22. doi: 10.1080/000155598433449.
• Whitney J, Phillips L, Aslam R, Barbul A, Gottrup F, Gould L, Robson MC, Rodeheaver G, Thomas D, Stotts N. Guidelines for the treatment of pressure ulcers. Wound Repair Regen. 2006 Nov-Dec;14(6):663-79. doi: 10.1111/j.1524-475X.2006.00175.x. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: September 2, 2009
• First Posted (ESTIMATE): September 3, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 27, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: DFU; diabetic foot ulcers; pressure ulcers; PU; Bates-Jensen Wound Assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 828-101-09-013