Clinical trial NCT00971048: Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
Official title: Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Pressure Ulcers
Keywords: pressure ulcers
PU
diabetic foot ulcers
DFU
Bates-Jensen Wound Assessment
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.
timeFrame: 22 - 29 days
Secondary outcomes:
measure: Number of Participants With Wound Closure by Day 22.
timeFrame: 22 days
measure: Pain Assessed by a 100-mm VAS Scale.
timeFrame: At every visit: Day 8, Day 15, Day 22, Day 29
measure: Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)
timeFrame: At every visit: Day 8, Day 15, Day 22, Day 29
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Trovare Clinical Research
state: California
city: Chula Vista
country: United States
facility: Absolute Foot Care
state: California
city: Fresno
country: United States
facility: Roy Kroeker
state: California
city: Los Angeles
country: United States
facility: Innovative Medical Technologies
state: California
city: San Diego
country: United States
facility: San Diego Research Center
state: California
city: Altamonte Springs
country: United States
facility: Foot and Ankle Associates of Florida
state: Florida
city: Des Plaines
country: United States
facility: Weil Foot and Ankle Institute
state: Illinois
city: Dallas
country: United States
facility: Prigoff-Bowers LLP
state: Texas
city: Dallas
country: United States
facility: Richard Galperin, DPM
state: Texas
city: San Antonio
country: United States
facility: Robert Wunderlich, DPM
state: Texas
city: St. George
country: United States
facility: Dixie Regional Wound Clinic
state: Utah
Study officials:
affiliation: Healthpoint, Ltd
name: Innes Cargill, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Frykberg RG. Epidemiology of the diabetic foot: ulcerations and amputations. Adv Wound Care. 1999 Apr;12(3):139-41. No abstract available.
citation: Sussman C, Bates-Jensen B. Wound Care - A Collaborative Practice Manual for Health Professionals. 3rd Ed. Philadelphia: Lippincott Williams & Wilkins, 2006.
citation: Hess CT. Wound Care. 5th Ed ed. Philadelphia: Lippincott Williams & Wilkins, 2005.
citation: 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.
citation: Agren MS. An amorphous hydrogel enhances epithelialisation of wounds. Acta Derm Venereol. 1998 Mar;78(2):119-22. doi: 10.1080/000155598433449.
citation: 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.