Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

Ulcer Healing Within 20 Weeks
Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.
20 weeks

Secondary Outcomes (1)

Ulcer Healing Within 12 Weeks.
12 weeks

Study Arms (1)

Weekly LeucoPatch treatment

OTHER

Weekly treatment of diabetic foot ulcers with LeucoPatch

Device: LeucoPatch treatment

Interventions

LeucoPatch treatmentDevice

weekly

Weekly LeucoPatch treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age \> 18 years
Type I or Type II Diabetes

Sponsors & Collaborators

Reapplix
Otherlead

Study Sites (7)

Knowledge Center for woundhealing, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic

Herlev, 2730, Denmark

Vascular Center, Wound Clinic Kolding Hospital

Kolding, 6000, Denmark

University center for woundhealing, Odense Hospital

Odense, 5000, Denmark

Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic

Ängelholm, 262 81, Sweden

Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Results Point of Contact

Title: MD, PhD Senior Consultant Magnus Löndahl
Organization: Reapplix Blokken 45 3460 Birkerød Denmark

Study Officials

Tonny Karlsmark, MD
Dept. of Dermatology D, Bispebjerg Hospital,
PRINCIPAL INVESTIGATOR
Bo Joergensen, MD
Dept. of Dermatology D, Bispebjerg Hospital,Denmark
STUDY DIRECTOR
Anna Marie Nielsen, MD
University Center for Wound Healing, Odense University Hospital, Denmark
STUDY DIRECTOR
Lise Tarnow, MD,MDSc
Steno Diabetes Center, Niels Steensensvej 2, 2820 Gentofte, Denmark
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

60 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 19, 2011

Study Start

October 2010

Date type not reported

This date has not been verified as actual or estimated.

LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Weekly LeucoPatch treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Weekly LeucoPatch treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations