Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
NCT ID: NCT00971048
Last Updated: 2014-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2009-09-30
2011-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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HP828-101
HP828-101
Topical test article applied once daily
Standard of Care
For DFU SoC is a hydrogel. For PU SoC is a hydrocolloid gel.
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
Interventions
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HP828-101
Topical test article applied once daily
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Healthpoint
INDUSTRY
Responsible Party
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Principal Investigators
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Innes Cargill, PhD
Role: STUDY_DIRECTOR
Healthpoint, Ltd
Locations
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Trovare Clinical Research
Bakersfield, California, United States
Absolute Foot Care
Chula Vista, California, United States
Roy Kroeker
Fresno, California, United States
Innovative Medical Technologies
Los Angeles, California, United States
San Diego Research Center
San Diego, California, United States
Foot and Ankle Associates of Florida
Altamonte Springs, Florida, United States
Weil Foot and Ankle Institute
Des Plaines, Illinois, United States
Prigoff-Bowers LLP
Dallas, Texas, United States
Richard Galperin, DPM
Dallas, Texas, United States
Robert Wunderlich, DPM
San Antonio, Texas, United States
Dixie Regional Wound Clinic
St. George, Utah, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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828-101-09-013
Identifier Type: -
Identifier Source: org_study_id
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