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

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971048
• Other study ID #: 828-101-09-013
• Status: Completed
• Phase: N/A
• First received: August 27, 2009
• Last updated: December 11, 2013
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2013
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Foot and Ankle Associates of Florida	Altamonte Springs	Florida
United States	Trovare Clinical Research	Bakersfield	California
United States	Absolute Foot Care	Chula Vista	California
United States	Prigoff-Bowers LLP	Dallas	Texas
United States	Richard Galperin, DPM	Dallas	Texas
United States	Weil Foot and Ankle Institute	Des Plaines	Illinois
United States	Roy Kroeker	Fresno	California
United States	Innovative Medical Technologies	Los Angeles	California
United States	Robert Wunderlich, DPM	San Antonio	Texas
United States	San Diego Research Center	San Diego	California
United States	Dixie Regional Wound Clinic	St. George	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

References & Publications (10)

Agren MS. An amorphous hydrogel enhances epithelialisation of wounds. Acta Derm Venereol. 1998 Mar;78(2):119-22. — View Citation

Andersen CA, Roukis TS. The diabetic foot. Surg Clin North Am. 2007 Oct;87(5):1149-77, x. Review. — View Citation

Frykberg RG. Epidemiology of the diabetic foot: ulcerations and amputations. Adv Wound Care. 1999 Apr;12(3):139-41. Review. — View Citation

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

HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. — View 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. — View 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. — View Citation

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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Wound Closure by Day 22.		22 days	No
Secondary	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	No
Secondary	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	No