Foot Ulcer, Diabetic Clinical Trial
Official title:
A Multi-centered, Prospective, Randomized, Double-blinded, Comparison of an Investigational Non-adherent Dressing to 3M Tegaderm Matrix Dressing With PHI Technology in the Management of Non-healing Diabetic Foot Ulcers
Verified date | March 2015 |
Source | 3M |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 30 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Is the subject 18 years of age or older? 2. 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? 3. Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided? 4. Does the subject show evidence of neuropathy? 5. 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? 6. Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes? 7. Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)? 8. Is the subject willing to have photos taken of their wound and permit use of the photos in publications? 9. 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? 10. 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.) 11. Is the subject able to comply with the protocol requirements? 12. 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? Exclusion Criteria: 1. Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit? 2. Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year? 3. Does the subject have an infection requiring systemic antibiotic treatment? 4. Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)? 5. 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.) 6. Does the subject have Lupus or Crohn's disease? 7. Does the subject have an oxygen dependency? 8. Has the subject received hyperbaric oxygen therapy within the previous 90 days? 9. Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit? 10. Does the subject have an active Charcot foot deformity of the foot presenting the ulcer? 11. Has the subject received Dermagraft®, Apligraf, or any other biologically active wound care product, or used Regranex Gel®, KGF, TGFß or another topical growth factor to the study ulcer within the 30 days prior to the Screening visit? 12. Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents? 13. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit? 14. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study? 15. Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit? |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wyatt Payne, MD | Bay Pines | Florida |
United States | Vickie Driver, DPM | Boston | Massachusetts |
United States | Alex Reyzelman, DPM | Castro Valley | California |
United States | William Marston, MD | Chapel Hill | North Carolina |
United States | Terry Treadwell, MD | Montgomery | Alabama |
United States | Joseph Boykin, MD | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
3M |
United States,
Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med. 2006 Jun;23(6):594-608. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
Gelfand JM, Hoffstad O, Margolis DJ. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol. 2002 Dec;119(6):1420-5. — View Citation
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. Retraction in: Int Wound J. 2014 Jun;11(3):342. — View Citation
Greener B, Hughes AA, Bannister NP, Douglass J. Proteases and pH in chronic wounds. J Wound Care. 2005 Feb;14(2):59-61. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Mustoe T. Understanding chronic wounds: a unifying hypothesis on their pathogenesis and implications for therapy. Am J Surg. 2004 May;187(5A):65S-70S. Review. — View Citation
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. — View Citation
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. — View Citation
Ravanti L, Kähäri VM. Matrix metalloproteinases in wound repair (review). Int J Mol Med. 2000 Oct;6(4):391-407. Review. — View Citation
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. — View Citation
Rushton I. Understanding the role of proteases and pH in wound healing. Nurs Stand. 2007 Apr 18-24;21(32):68, 70, 72 passim. Review. — View Citation
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. — View Citation
Schönfelder 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. — View Citation
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. Review. — View Citation
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. — View Citation
Smeets R, Ulrich D, Unglaub F, Wöltje 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. — View Citation
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. — View Citation
Steed DL. Wound-healing trajectories. Surg Clin North Am. 2003 Jun;83(3):547-55, vi-vii. Review. — View Citation
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. Epub 2007 Mar 27. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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