Evaluation of Windowed Casts With and Without Regranex® Gel for Healing Diabetic Neuropathic Ulcers

NCT00446472 | Unknown

• 1 other identifier: #778
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.

Conditions

Diabetic Foot Ulcers

Keywords

diabetes mellitus; diabetic neuropathies; peripheral vascular diseases

Outcome Measures

Primary Outcomes (1)

• Completely healed wounds

  4 months

Study Arms (2)

1

EXPERIMENTAL

Randomized to Regranex gel

Drug: Regranex®

2

ACTIVE COMPARATOR

Placebo hydrogel will be used for a total of 16 weeks

Drug: Hydrogel

Interventions

Regranex® DRUG

Regranex gel will be used for a total of 16 weeks

Also known as: Becaplermin

1

Hydrogel DRUG

Placebo hydrogel will be applied for 16 weeks

2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must sign an informed consent
• Have a history of compliance and reliability in following study required treatment regimen.
• Have diabetic mellitus Type I or Type II and have a glycohemoglobin Alc less than l0
• Presence of one or two ulcers in lower extremities
• Wounds cannot be positioned more than 2.5cm proximal to the malleoli, but may involve any more distal position of the foot
• Type 2 Diabetic Mellitus Neuropathic ulcers present at least for 3months with failure to heal
• Post-operation wounds in DM patients with wound present for minimum 4 weeks after surgery and wound surface area has failed to decrease more than 20% in 4 weeks
• Ulcer(s) must be stage II or III full-thickness (extending through the subcutaneous tissue or beyond - Wagner grade II or III)
• No joint, tendon or bone exposure
• Located on the lower extremity.
• Ulcer size measures 1cm2 \< 16 cm2
• No osteomyelitis affecting the area of the ulcer
• If two wounds, both can be incorporated into one window when cast applied
• Adequate foot arterial circulation evidenced by palpable ankle pulses or Doppler with ABI less than or equal to 0.8. If non-compressible, must have triphasic wave Doppler velocity waveforms or toe/brachial pressure greater than or equal to 0.6.

You may not qualify if:

• Female subjects who are within child bearing age range.
• Previous sensitivity to Regranex® Gel.
• Use of topical antibiotics, enzymatic debriders on the selected ulcer(s) within 30 days preceding randomization.
• Osteomyelitis affecting the area of the selected ulcer(s)
• Exposed bone, joint or tendon at ulcer site (Wagner III or higher)
• Presence of more than two full-thickness ulcers on targeted lower extremity
• Requirement for systemic antibiotics use within 7 days of study entry
• Inability to tolerate cast
• Presence of systemic or local cancer of any kind
• Life expectancy less than 1 year
• Subjects with end stage renal failure requiring chronic hemodialysis
• Concomitant use of Pletal or other vasodilators
• Ankle Brachial Index less or equal to 0.8 or toe pressure index less than 0.6
• ESR\>20
• Demonstration of poor compliance including a chronic alcohol, psychiatric condition or drug abuse problems

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead
• Heritage Medical Research Institute: collaborator

Study Sites (2)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

RECRUITING

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

RECRUITING

Related Publications (10)

• Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001 Jun;24(6):1019-22. doi: 10.2337/diacare.24.6.1019.

  PMID: 11375363 BACKGROUND

• Ha Van G, Siney H, Hartmann-Heurtier A, Jacqueminet S, Greau F, Grimaldi A. Nonremovable, windowed, fiberglass cast boot in the treatment of diabetic plantar ulcers: efficacy, safety, and compliance. Diabetes Care. 2003 Oct;26(10):2848-52. doi: 10.2337/diacare.26.10.2848.

  PMID: 14514590 BACKGROUND

• Caravaggi C, Faglia E, De Giglio R, Mantero M, Quarantiello A, Sommariva E, Gino M, Pritelli C, Morabito A. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study. Diabetes Care. 2000 Dec;23(12):1746-51. doi: 10.2337/diacare.23.12.1746.

  PMID: 11128345 BACKGROUND

• Armstrong DG, Lavery LA, Kimbriel HR, Nixon BP, Boulton AJ. Activity patterns of patients with diabetic foot ulceration: patients with active ulceration may not adhere to a standard pressure off-loading regimen. Diabetes Care. 2003 Sep;26(9):2595-7. doi: 10.2337/diacare.26.9.2595.

  PMID: 12941724 BACKGROUND

• Armstrong DG, Lavery LA, Wu S, Boulton AJ. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Diabetes Care. 2005 Mar;28(3):551-4. doi: 10.2337/diacare.28.3.551.

  PMID: 15735186 BACKGROUND

• Larsson J, Apelqvist J, Agardh CD, Stenstrom A. Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach? Diabet Med. 1995 Sep;12(9):770-6. doi: 10.1111/j.1464-5491.1995.tb02078.x.

  PMID: 8542736 BACKGROUND

• Pecoraro RE, Ahroni JH, Boyko EJ, Stensel VL. Chronology and determinants of tissue repair in diabetic lower-extremity ulcers. Diabetes. 1991 Oct;40(10):1305-13. doi: 10.2337/diab.40.10.1305.

  PMID: 1936593 BACKGROUND

• Bergink GJ, Hoyng CB, van der Maazen RW, Vingerling JR, van Daal WA, Deutman AF. A randomized controlled clinical trial on the efficacy of radiation therapy in the control of subfoveal choroidal neovascularization in age-related macular degeneration: radiation versus observation. Graefes Arch Clin Exp Ophthalmol. 1998 May;236(5):321-5. doi: 10.1007/s004170050085.

  PMID: 9602314 BACKGROUND

• U.S. Department of Health and Human Services. Healthy People 2010: Understanding and improving health, vol.2. Washington, DC: US Government Printing Office, 2000

  BACKGROUND

• Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation. Basis for prevention. Diabetes Care. 1990 May;13(5):513-21. doi: 10.2337/diacare.13.5.513.

  PMID: 2351029 BACKGROUND

Related Links

• Southern California Institute for Research and Education (SCIRE) Website

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Diabetic Neuropathies; Peripheral Vascular Diseases

Interventions

Becaplermin; Hydrogels

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors; Gels; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ian Gordon, M.D., Ph.D.

  VA Long Beach Healthcare System

  PRINCIPAL INVESTIGATOR

• Aksone Nouvong, D.P.M.

  VA Greater Los Angeles Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 12, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 4, 2010

Record last verified: 2010-06

Locations

US (2)