NCT00804414

Brief Summary

Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 26, 2010

Status Verified

January 1, 2010

Enrollment Period

10 months

First QC Date

December 5, 2008

Last Update Submit

January 25, 2010

Conditions

DiabetesDiabetic Ulcer

Keywords

DiabetesDiabetic ulcerChronic ulcerSBG

Outcome Measures

Primary Outcomes (1)

  • Compare the proportion of patients in the two arms who have complete healing of target ulcer

    Maximum 12 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: SBG

2

PLACEBO COMPARATOR
Drug: Placebo Comparator

Interventions

SBGDRUG

Solution for topical use

1
Placebo ComparatorDRUG

Solutin for topical use

2

Eligibility Criteria

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

You may qualify if:

  • Patients with chronic diabetic foot ulcer

You may not qualify if:

  • Insufficient nutritional status, renal function or diabetes control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

January 26, 2010

Record last verified: 2010-01

Locations

ES(1)