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

Primary Purpose

Diabetic Foot Ulcers

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

LeucoPatch treatment

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years
Type I or Type II Diabetes
Age of wounds > 6 weeks
Wound area <10 cm2
Wounds: Texas degree ≤ type IIa
Perfusion status: toe pressure> 30 mmHg, or transcutaneous oxygen measurement (TcPO2)> 30 mmHg on the foot (measured within the last 3 months) or palpable foot pulse (equivalent to> 60 mmHg)
Diabetes control: HbA1c <12%
Adequate off-loading (Walker, therapy sandals etc.)
The patient can adhere to the treatment protocol and is expected to conclude the study
Written informed consent

Exclusion Criteria:

Non-Danish or Swedish speaking
Dementia
Pregnant or nursing women
The patient cannot tolerate blood donation
Hemoglobin : < 6,5 mmol/l or 105 g/l
Haemophilia, Sickle cell anemia, severe thrombocytopenia, and leukemia or blood dyscrasias.
Patient on dialysis
Clinical signs of infection - including osteomyelitis (probe to bone).
Necrosis of the wound
40% change (+/-) in ulcer area in a 2-week run-in period with optimal therapy.
Blood vessel reconstruction within the last 4 weeks.
Participation in other clinical wound healing studies in the last 30 days.
Failure to comply with study protocol in the 2-week run-in period.

Sites / Locations

Knowledge Center for woundhealing, Bispebjerg Hospital
Steno Diabetes Center
Herlev Hospital, Orthopaedic Surgery Infirmary, Wound Clinic
Vascular Center, Wound Clinic Kolding Hospital
University center for woundhealing, Odense Hospital
Skane University Hospital, Dept. of Endocrinology, Diabetes Foot Ulcer Clinic
Ängelholm Hospital, Dept. of Medicine, Diabetic Foot Ulcer Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Weekly LeucoPatch treatment

Arm Description

Weekly treatment of diabetic foot ulcers with LeucoPatch

Outcomes

Primary Outcome Measures

Ulcer Healing Within 20 Weeks

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

Secondary Outcome Measures

Ulcer Healing Within 12 Weeks.

Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population

Full Information

NCT ID

NCT01454401

First Posted

October 14, 2011

Last Updated

March 29, 2023

Sponsor

Reapplix

1. Study Identification

Unique Protocol Identification Number

NCT01454401

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Reapplix

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.

Detailed Description

Summary: Treatment Study The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE (European Conformity) marked LeucoPatch™ Device and contains no additives. In this treatment study up to 75 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved. The primary endpoint is time to complete healing, the secondary endpoint is change in wound size.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weekly LeucoPatch treatment

Arm Type

Other

Arm Description

Weekly treatment of diabetic foot ulcers with LeucoPatch

Intervention Type

Device

Intervention Name(s)

LeucoPatch treatment

Intervention Description

weekly

Primary Outcome Measure Information:

Title

Ulcer Healing Within 20 Weeks

Description

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

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

Ulcer Healing Within 12 Weeks.

Description

Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years Type I or Type II Diabetes Age of wounds > 6 weeks Wound area <10 cm2 Wounds: Texas degree ≤ type IIa Perfusion status: toe pressure> 30 mmHg, or transcutaneous oxygen measurement (TcPO2)> 30 mmHg on the foot (measured within the last 3 months) or palpable foot pulse (equivalent to> 60 mmHg) Diabetes control: HbA1c <12% Adequate off-loading (Walker, therapy sandals etc.) The patient can adhere to the treatment protocol and is expected to conclude the study Written informed consent Exclusion Criteria: Non-Danish or Swedish speaking Dementia Pregnant or nursing women The patient cannot tolerate blood donation Hemoglobin : < 6,5 mmol/l or 105 g/l Haemophilia, Sickle cell anemia, severe thrombocytopenia, and leukemia or blood dyscrasias. Patient on dialysis Clinical signs of infection - including osteomyelitis (probe to bone). Necrosis of the wound 40% change (+/-) in ulcer area in a 2-week run-in period with optimal therapy. Blood vessel reconstruction within the last 4 weeks. Participation in other clinical wound healing studies in the last 30 days. Failure to comply with study protocol in the 2-week run-in period.

Overall Study Officials: