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Diabetic Foot UlcersNCT00446472

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

A study testing Regranex® and Hydrogel in people with Diabetic Foot Ulcers, run by Southern California Institute for Research and Education at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 85 years
Conditions the study is for
Diabetic Foot Ulcers
What is being tested?
Regranex® and Hydrogel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
Apr 2007to Sep 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites, 2 recruiting

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

    Christine Ma Agas, 562-826-8000 ext. 2889, christine.ma@va.gov

    Ian Gordon, M.D., Ph.D.

    Recruiting

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

    Aksone Nouvong, D.P.M., 310-268-3193, aksone.nouvong@va.gov

    Aksone Nouvong, D.P.M.

    Recruiting

Other trials in United States

About this study

Official title: Evaluation of Windowed Casts With and Without Regranex® Gel for Healing

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.

Read the detailed description

Management of diabetic leg or foot ulcers is based on certain principals: 1) effective off-loading of pressure on the wound via specialized shoes, cast braces, or casts, 2) removal of infected or necrotic tissue vial surgery or non-surgical methods, and 3) optimization of wound healing by interventions that promote wound repair such as nutritional support, provision of optimal moisture balance and growth factor therapy.

Application of casts or cast braces [below knee, removable boots with protective padding] to protect and immobilize the ankle and foot have been demonstrated to provide superior wound healing than less cumbersome types of shoe gear (1-3). The benefit of casting may be the result of more effective off-loading of pressure than can be achieved with other devices, but the inability of patients to remove their casts also appears to an important factor, as non-compliance with removable cast-braces has been shown to be a pervasive and significant issue (4,5). One critical concept in diabetic foot ulcer management is the relation between chronically and limb loss - for each year a wound persists, a patient has a 25% risk for major amputation due to complications from infection (6-8). Limb loss has a profound effect on Diabetics' quality of life and rate of lower limb loss among diabetics is four per 1,000 person years in comparison with three per 10,000 person years (9-10).

Being tested
Regranex®, Hydrogel
Keywords
diabetes mellitus, diabetic neuropathies, peripheral vascular diseases
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Diabetic Neuropathies, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regranex®Drug

    Also called Becaplermin

    Regranex gel will be used for a total of 16 weeks

  • HydrogelDrug

    Placebo hydrogel will be applied for 16 weeks

Study groups in NCT00446472
Study groupRoleWhat they receive
1ExperimentalRandomized to Regranex gel
Receives: Drug: Regranex®
2Active comparatorPlacebo hydrogel will be used for a total of 16 weeks
Receives: Drug: Hydrogel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Completely healed wounds

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionSep 2010 (estimated)
  4. Study completionSep 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00446472
Sponsor's protocol ID
#778
Status last verified
Jun 2010
First submitted
8 Mar 2007
Last updated
4 Jun 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11375363

  • 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.

    PubMed 14514590

  • 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.

    PubMed 11128345

  • 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.

    PubMed 12941724

  • 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.

    PubMed 15735186

  • 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.

    PubMed 8542736

  • 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.

    PubMed 1936593

  • 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.

    PubMed 9602314

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

  • 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.

    PubMed 2351029

Questions about this trial

What is this clinical trial studying?

A study testing Regranex® and Hydrogel in people with Diabetic Foot Ulcers, run by Southern California Institute for Research and Education at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completely healed wounds (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00446472, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2010.

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