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

NCT00971048 | Completed Results

• 1 other identifier: 828-101-09-013
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Diabetic Foot Ulcers; Pressure Ulcers

Keywords

pressure ulcers; PU; diabetic foot ulcers; DFU; Bates-Jensen Wound Assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)

  At every visit: Day 8, Day 15, Day 22, Day 29

Study Arms (2)

HP828-101

EXPERIMENTAL

Device: HP828-101

Standard of Care

ACTIVE COMPARATOR

For DFU SoC is a hydrogel. For PU SoC is a hydrocolloid gel.

Device: Hydrogel/Hydrocolloid

Interventions

HP828-101 DEVICE

Topical test article applied once daily

Also known as: New device, no brand name identified-Code name is HP828-101

HP828-101

Hydrogel/Hydrocolloid DEVICE

Hydrogel for DFU and Hydrocolloid for PU (3M Tegaderm Hydrogel for DFU; ConvaTec DuoDERM Hydroactive Gel for PU); Topical test articles applied once daily

Also known as: 3M Tegaderm Hydrogel for DFU, ConvaTec DuoDERM Hydroactive Gel for PU

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (11)

Trovare Clinical Research

Bakersfield, California, 93311, United States

Location

Absolute Foot Care

Chula Vista, California, 91910, United States

Location

Roy Kroeker

Fresno, California, 93710, United States

Location

Innovative Medical Technologies

Los Angeles, California, 90063, United States

Location

San Diego Research Center

San Diego, California, 92103, United States

Location

Foot and Ankle Associates of Florida

Altamonte Springs, Florida, 32701, United States

Location

Weil Foot and Ankle Institute

Des Plaines, Illinois, 60016, United States

Location

Prigoff-Bowers LLP

Dallas, Texas, 75224, United States

Location

Richard Galperin, DPM

Dallas, Texas, 75224, United States

Location

Robert Wunderlich, DPM

San Antonio, Texas, 78212, United States

Location

Dixie Regional Wound Clinic

St. George, Utah, 84770, United States

Location

Related Publications (10)

• 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.

  PMID: 12394337 BACKGROUND

• 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.

  PMID: 7553187 BACKGROUND

• 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.

  PMID: 14087904 BACKGROUND

• 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.

  PMID: 17936480 BACKGROUND

• Frykberg RG. Epidemiology of the diabetic foot: ulcerations and amputations. Adv Wound Care. 1999 Apr;12(3):139-41. No abstract available.

  PMID: 10655794 BACKGROUND

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

  BACKGROUND

• Hess CT. Wound Care. 5th Ed ed. Philadelphia: Lippincott Williams & Wilkins, 2005.

  BACKGROUND

• 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.

  PMID: 17199833 BACKGROUND

• Agren MS. An amorphous hydrogel enhances epithelialisation of wounds. Acta Derm Venereol. 1998 Mar;78(2):119-22. doi: 10.1080/000155598433449.

  PMID: 9534889 BACKGROUND

• 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.

  PMID: 17199832 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Results Point of Contact

• Title: Jaime Dickerson, PhD
• Organization: Smith & Nephew Biotherapeutics

jaime.dickerson@smith-nephew.com

817-302-3914

Study Officials

• Innes Cargill, PhD

  Healthpoint, Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: September 3, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 27, 2014
• Results First Posted: January 27, 2014

Record last verified: 2013-12

Locations

US (11)