NCT01068171

Brief Summary

The purpose of this study is to determine which treatment, over 6 months, will promote healing of diabetic foot ulcers that are not infected in the most efficient, cost-effective way.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

February 11, 2010

Last Update Submit

November 3, 2020

Conditions

Diabetic Foot Ulcers

Keywords

diabetesfoot ulcersoff-loadingcollagenWagner 1

Outcome Measures

Primary Outcomes (1)

  • decrease in size of wound

    6 months

Secondary Outcomes (1)

  • non-healing wound

    6 months or less

Study Arms (6)

shoe, plain dressing

ACTIVE COMPARATOR

post-op shoe with plain occlusive dressing

Other: type of footwear

shoe, collagen

ACTIVE COMPARATOR

post-op shoe with collagen dressing

Other: collagen dressing with and without silver

boot, plain dressing

ACTIVE COMPARATOR

air boot with occlusive dressing

Other: type of footwear

boot, collagen

ACTIVE COMPARATOR

air boot with collagen dressing

Other: collagen dressing with and without silver

monitored air boot, plain dressing

ACTIVE COMPARATOR

air boot with retention strap to monitor whether boot is removed with occlusive dressing

Other: type of footwear

monitored boot with collagen

ACTIVE COMPARATOR

air boot with retention strap to monitor whether boot is removed with collagen dressing

Other: collagen dressing with and without silver

Interventions

type of footwearOTHER

comparison of results between post-op shoe, air boot which the patient can remove ad lib and air boot whose removal can be monitored

Also known as: DJO XP Diabetic Walker, Camcon Medical postoperative shoe, Smith and Nephew Allevyn Foam dressing
boot, plain dressingmonitored air boot, plain dressingshoe, plain dressing
collagen dressing with and without silverOTHER

silver-impregnated collagen dressing will be used for 2 weeks, then plain collagen dressing will be used for the remainder of the 6 months

Also known as: Smith & Nephew Biostep dressing with Allevyn Foam cover, Smith & Nephew Biostep Ag gressing with Allevyn Foam cover
boot, collagenmonitored boot with collagenshoe, collagen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult - over 18 years of age
  • Diabetes with an A1c of less than or equal to 9% - if no A1c result is available within the past 3 months, one will be drawn to qualify the patient for the study
  • No evidence of circulatory compromise
  • Posterior tibial or pedal pulse present on palpation
  • No pallor on elevation
  • No dependent rubor
  • Loss of sensation on forefoot using monofilament
  • Wound or callus on only 1 foot
  • Wound Classification - Wagner Grade 1, non-infected
  • Ulcer present for 1 - 3 months
  • Ulcer of forefoot only
  • No previous ulcer of that foot or amputation of either extremity
  • Wound size \< 1" diameter
  • Wound bed pink

You may not qualify if:

  • Diagnoses with unpredictable trajectory or healing ability, i.e.
  • Psychiatric disorders
  • Cancer
  • ESRD not eligible for dialysis
  • HIV
  • Previous lower extremity amputation
  • Charcot foot
  • Evidence of circulatory compromise
  • Absence of pulses
  • Decreased capillary refill (\> 3 seconds)
  • Trophic skin changes - shiny, hairless toes
  • Ankle Brachial Index \< 0.8

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harris County Hospital District Community Health

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Diabetic FootDiabetes MellitusFoot Ulcer

Interventions

Silver

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Gary Lepow, DPM

    University of Texas Health Science at Houston, Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Talar L Glover, MS, RN, CNS

    Harris County Hospital District

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

US(1)