Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Malleoli Ulcers Malleoli Ulcers

Keywords

Malleoli ulcersDiabetesHealingDressingLeucoPatch

Outcome Measures

Primary Outcomes (1)

Healing of malleoli ulcer (YES/NO)
Confirmed by a blinded observer
up to 24 weeks of treatment

Secondary Outcomes (6)

Time to healing of malleoli ulcer
24 weeks
Ulcer area reduction based on Image J measured on acetate drawing
24 weeks
Health related quality of life questionnaire SF12
week 0, week 12, and week 24
Health related quality of life questionnaire EQ-5D
week 0, week 12, and week 24
Pain at ulcer location
week 0, week 6, week 12 and week 24
+1 more secondary outcomes

Study Arms (2)

LeucoPatch

EXPERIMENTAL

Treatment with usual ulcer care and LeucoPatch once weekly up til 24 weeks or until healing.

Other: LeucoPatch

Usual care followed by LeucoPatch

ACTIVE COMPARATOR

Usual care weekly for 12 weeks, if the ulcer persist after the12 weeks LeucoPatch treatment will be started for up to 12 weeks or until healing.

Other: LeucoPatch

Interventions

LeucoPatchOther

LeucoPatch is an fully autologous growth factor-containing dressing

LeucoPatchUsual care followed by LeucoPatch

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:

Foot ulcer at the malleoli area between 0,25 cm² and 5,0 cm²
Foot ulcer duration more than 6 weeks

Sponsors & Collaborators

Study Sites (6)

Bispebjerg hospital

Copenhagen, Capital Region, 2400, Denmark

Viborg Sygehus

Viborg, Region Midt, 8800, Denmark

Nordsjaellands Hospital

Hillerød, Regionh, 3400, Denmark

Herlev-Gentofte Hospital

Herlev, Denmark

Kolding Sygehus

Kolding, Denmark

Skaane University Hospital

Lund, Sweden

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Lise Tarnow, Professsor
Nordsjaellands Hospital
STUDY DIRECTOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 8, 2016

Study Start

November 2016

Date type not reported

This date has not been verified as actual or estimated.

LeucoPatch in Malleoli Ulcer Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

LeucoPatch

Usual care followed by LeucoPatch

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

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

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

LeucoPatch

Usual care followed by LeucoPatch

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations