A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers

NCT01013792 | Terminated Results

• 1 other identifier: 05-011091
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief Summary

The primary objective is to:

• Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer. Secondary objectives are to:
• Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.
• Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.
• Assess and compare the impact that these dressings have on patients' quality of life.
• Assess the wound's biological response and pH to the study dressings.

Conditions

Foot Ulcer, Diabetic

Keywords

Diabetic; Foot; Ulcer; Neuropathic; Tegaderm Matrix Dressing; DFU; Wound Care; PHI

Outcome Measures

Primary Outcomes (1)

• Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit

  A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as \[(Baseline - Week 8)/Baseline\] x 100%.

  up to 8 weeks

Study Arms (2)

Non-adherent Wound Dressing

EXPERIMENTAL

The non-adherent dressing is the same as the Tegaderm Matrix dressing, with potassium chloride, rubidium chloride, calcium chloride, zinc chloride, potassium citrate and citric acid removed. This dressing is a Class I medical device (21 CFR Sec. 878.4020 Occlusive wound dressing) that is exempt from premarket notification procedures.

Device: Wound Dressing

Tegaderm Matrix Dressing with PHI

ACTIVE COMPARATOR

A commercial wound dressing to be used per manufacturer's instructions for use.

Device: Wound Dressing

Interventions

Wound Dressing DEVICE

Acetate mesh carrier with ointment (water, PEGs)

Non-adherent Wound Dressing

Eligibility Criteria

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

You may qualify if:

• Is the subject 18 years of age or older?
• Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks?
• Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
• Does the subject show evidence of neuropathy?
• Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis?
• Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?
• Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?
• Is the subject willing to have photos taken of their wound and permit use of the photos in publications?
• Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information?
• Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 - 1.2; or if the ABI is greater than 1.2, does the subject show toe pressures \>40 mmHg, or transcutaneous oximetry (TcPO2) \> 40 mm Hg, or does the subject show adequate circulation on an arterial Doppler study? (ABI or Doppler results must be \< 45 days old.)
• Is the subject able to comply with the protocol requirements?
• If the subject is a woman of child bearing potential is she practicing an acceptable form of birth control as determined by the Investigator, and is she willing to have a pregnancy test?

You may not qualify if:

• Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
• Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
• Does the subject have an infection requiring systemic antibiotic treatment?
• Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
• Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.)
• Does the subject have Lupus or Crohn's disease?
• Does the subject have an oxygen dependency?
• Has the subject received hyperbaric oxygen therapy within the previous 90 days?
• Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit?
• Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?
• Has the subject received Dermagraft®, Apligraf, or any other biologically active wound care product, or used Regranex Gel®, KGF, TGFβ or another topical growth factor to the study ulcer within the 30 days prior to the Screening visit?
• Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents?
• Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
• Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
• Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (6)

Terry Treadwell, MD

Montgomery, Alabama, 36111, United States

Location

Alex Reyzelman, DPM

Castro Valley, California, 94546, United States

Location

Wyatt Payne, MD

Bay Pines, Florida, 33744, United States

Location

Vickie Driver, DPM

Boston, Massachusetts, 02118, United States

Location

William Marston, MD

Chapel Hill, North Carolina, 27599, United States

Location

Joseph Boykin, MD

Richmond, Virginia, 23220, United States

Location

Related Publications (30)

• Schultz G, Mozingo D, Romanelli M, Claxton K. Wound healing and TIME; new concepts and scientific applications. Wound Repair Regen. 2005 Jul-Aug;13(4 Suppl):S1-11. doi: 10.1111/j.1067-1927.2005.1304S1.x. No abstract available.

  PMID: 16008735 BACKGROUND

• Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.

  PMID: 15230830 BACKGROUND

• Mustoe T. Understanding chronic wounds: a unifying hypothesis on their pathogenesis and implications for therapy. Am J Surg. 2004 May;187(5A):65S-70S. doi: 10.1016/S0002-9610(03)00306-4.

  PMID: 15147994 BACKGROUND

• Falanga V. The chronic wound: impaired healing and solutions in the context of wound bed preparation. Blood Cells Mol Dis. 2004 Jan-Feb;32(1):88-94. doi: 10.1016/j.bcmd.2003.09.020.

  PMID: 14757419 BACKGROUND

• Xu L, McLennan SV, Lo L, Natfaji A, Bolton T, Liu Y, Twigg SM, Yue DK. Bacterial load predicts healing rate in neuropathic diabetic foot ulcers. Diabetes Care. 2007 Feb;30(2):378-80. doi: 10.2337/dc06-1383. No abstract available.

  PMID: 17259515 BACKGROUND

• Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med. 2006 Jun;23(6):594-608. doi: 10.1111/j.1464-5491.2006.01773.x.

  PMID: 16759300 BACKGROUND

• Steed DL. Wound-healing trajectories. Surg Clin North Am. 2003 Jun;83(3):547-55, vi-vii. doi: 10.1016/S0039-6109(02)00208-6.

  PMID: 12822725 BACKGROUND

• Robson MC, Hill DP, Woodske ME, Steed DL. Wound healing trajectories as predictors of effectiveness of therapeutic agents. Arch Surg. 2000 Jul;135(7):773-7. doi: 10.1001/archsurg.135.7.773.

  PMID: 10896369 BACKGROUND

• Margolis DJ, Gelfand JM, Hoffstad O, Berlin JA. Surrogate end points for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2003 Jun;26(6):1696-700. doi: 10.2337/diacare.26.6.1696.

  PMID: 12766096 BACKGROUND

• Gelfand JM, Hoffstad O, Margolis DJ. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol. 2002 Dec;119(6):1420-5. doi: 10.1046/j.1523-1747.2002.19629.x.

  PMID: 12485449 BACKGROUND

• Sheehan P, Jones P, Giurini JM, Caselli A, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):239S-244S. doi: 10.1097/01.prs.0000222891.74489.33.

  PMID: 16799391 BACKGROUND

• Steed DL, Hill DP, Woodske ME, Payne WG, Robson MC. Wound-healing trajectories as outcome measures of venous stasis ulcer treatment. Int Wound J. 2006 Mar;3(1):40-7. doi: 10.1111/j.1742-4801.2006.00178.x.

  PMID: 16650209 BACKGROUND

• Kantor J, Margolis DJ. A multicentre study of percentage change in venous leg ulcer area as a prognostic index of healing at 24 weeks. Br J Dermatol. 2000 May;142(5):960-4. doi: 10.1046/j.1365-2133.2000.03478.x.

  PMID: 10809855 BACKGROUND

• Greener B, Hughes AA, Bannister NP, Douglass J. Proteases and pH in chronic wounds. J Wound Care. 2005 Feb;14(2):59-61. doi: 10.12968/jowc.2005.14.2.26739. No abstract available.

  PMID: 15739652 BACKGROUND

• Karim RB, Brito BL, Dutrieux RP, Lassance FP, Hage JJ. MMP-2 assessment as an indicator of wound healing: A feasibility study. Adv Skin Wound Care. 2006 Jul-Aug;19(6):324-7. doi: 10.1097/00129334-200607000-00011.

  PMID: 16885646 BACKGROUND

• Pirayesh A, Dessy LA, Rogge FJ, Hoeksema HJ, Sinove YM, Dall' Antonia A, Jawad MA, Gilbert PM, Rubino C, Scuderi N, Blondeel R, Monstrey S. The efficacy of a polyhydrated ionogen impregnated dressing in the treatment of recalcitrant diabetic foot ulcers: a multi-centre pilot study. Acta Chir Belg. 2007 Nov-Dec;107(6):675-81. doi: 10.1080/00015458.2007.11680145.

  PMID: 18274183 BACKGROUND

• van Rossum M, Vooijs DP, Walboomers XF, Hoekstra MJ, Spauwen PH, Jansen JA. The influence of a PHI-5-loaded silicone membrane, on cutaneous wound healing in vivo. J Mater Sci Mater Med. 2007 Jul;18(7):1449-56. doi: 10.1007/s10856-006-0112-z. Epub 2007 Mar 27.

  PMID: 17387598 BACKGROUND

• Schmidtchen A, Wolff H, Hansson C. Differential proteinase expression by Pseudomonas aeruginosa derived from chronic leg ulcers. Acta Derm Venereol. 2001 Nov-Dec;81(6):406-9. doi: 10.1080/000155501317208336.

  PMID: 11859942 BACKGROUND

• Edwards JV, Howley PS. Human neutrophil elastase and collagenase sequestration with phosphorylated cotton wound dressings. J Biomed Mater Res A. 2007 Nov;83(2):446-54. doi: 10.1002/jbm.a.31171.

  PMID: 17477392 BACKGROUND

• Rushton I. Understanding the role of proteases and pH in wound healing. Nurs Stand. 2007 Apr 18-24;21(32):68, 70, 72 passim. doi: 10.7748/ns2007.04.21.32.68.c4499.

  PMID: 17479791 BACKGROUND

• Gethin GT, Cowman S, Conroy RM. The impact of Manuka honey dressings on the surface pH of chronic wounds. Int Wound J. 2008 Jun;5(2):185-94. doi: 10.1111/j.1742-481X.2007.00424.x.

  PMID: 18494624 BACKGROUND

• Wysocki AB, Staiano-Coico L, Grinnell F. Wound fluid from chronic leg ulcers contains elevated levels of metalloproteinases MMP-2 and MMP-9. J Invest Dermatol. 1993 Jul;101(1):64-8. doi: 10.1111/1523-1747.ep12359590.

  PMID: 8392530 BACKGROUND

• Ravanti L, Kahari VM. Matrix metalloproteinases in wound repair (review). Int J Mol Med. 2000 Oct;6(4):391-407.

  PMID: 10998429 BACKGROUND

• Muller M, Trocme C, Lardy B, Morel F, Halimi S, Benhamou PY. Matrix metalloproteinases and diabetic foot ulcers: the ratio of MMP-1 to TIMP-1 is a predictor of wound healing. Diabet Med. 2008 Apr;25(4):419-26. doi: 10.1111/j.1464-5491.2008.02414.x.

  PMID: 18387077 BACKGROUND

• Schonfelder U, Abel M, Wiegand C, Klemm D, Elsner P, Hipler UC. Influence of selected wound dressings on PMN elastase in chronic wound fluid and their antioxidative potential in vitro. Biomaterials. 2005 Nov;26(33):6664-73. doi: 10.1016/j.biomaterials.2005.04.030.

  PMID: 15978664 BACKGROUND

• Veves A, Sheehan P, Pham HT. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Arch Surg. 2002 Jul;137(7):822-7. doi: 10.1001/archsurg.137.7.822.

  PMID: 12093340 BACKGROUND

• Smeets R, Ulrich D, Unglaub F, Woltje M, Pallua N. Effect of oxidised regenerated cellulose/collagen matrix on proteases in wound exudate of patients with chronic venous ulceration. Int Wound J. 2008 Jun;5(2):195-203. doi: 10.1111/j.1742-481X.2007.00367.x.

  PMID: 18494625 BACKGROUND

• Lobmann R, Zemlin C, Motzkau M, Reschke K, Lehnert H. Expression of matrix metalloproteinases and growth factors in diabetic foot wounds treated with a protease absorbent dressing. J Diabetes Complications. 2006 Sep-Oct;20(5):329-35. doi: 10.1016/j.jdiacomp.2005.08.007.

  PMID: 16949521 BACKGROUND

• Fasciglione GF, Marini S, D'Alessio S, Politi V, Coletta M. pH- and temperature-dependence of functional modulation in metalloproteinases. A comparison between neutrophil collagenase and gelatinases A and B. Biophys J. 2000 Oct;79(4):2138-49. doi: 10.1016/S0006-3495(00)76461-7.

  PMID: 11023917 BACKGROUND

• Nwomeh BC, Liang HX, Cohen IK, Yager DR. MMP-8 is the predominant collagenase in healing wounds and nonhealing ulcers. J Surg Res. 1999 Feb;81(2):189-95. doi: 10.1006/jsre.1998.5495.

  PMID: 9927539 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Ulcer

Interventions

Bandages

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Joseph V. Boykin, Jr., MD
• Organization: HCA Retreat Hospital, Institute of Plastic and Reconstructive Surgery

joseph.boykin@HCAhealthcare.com

804-353-8100

Study Officials

• Joseph V Boykin, MD

  HCA Retreat Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 2, 2024
• Results First Posted: March 23, 2015

Record last verified: 2024-09

Locations

US (6)