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Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

Primary Purpose

Varicose Ulcer

Status

Terminated

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Tiscover

AS210

About this trial

This is an interventional treatment trial for Varicose Ulcer

Eligibility Criteria

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

Inclusion criteria:

Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3)
Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth < 1 cm
Target ulcer duration ≥ 12 weeks but ≤ 15 years
Acceptable state of health and nutrition
Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations

Exclusion Criteria:

History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
Refusal of or inability to tolerate compression therapy.
Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
>30% change of wound size in 4 weeks or confirmed by historical data
Presence of deep vein thrombosis or contra indication for compression therapy
Severe co-morbidity reducing life expectance to < 1 year
Use of oral corticosteroids and/or cytostatics >20 mg/per day;
Severe infection of ulcer, active cellulitis, osteomyelitis
Severe malnutrition
Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol)
Anaemia Hb <6 mmol/l

Sites / Locations

Centrum Oosterwal
Flevo Ziekenhuis, afdeling dermatologie
VU University Medical center
St. Fransiscus Gasthuis
Isala Ziekenhuis, dermatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

autologous cultured skin

acellular donor dermis

Arm Description

autologous cultured skin patches (Tiscover) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new Tiscover patches.

acellular donor dermis (AS210) is applied on wound in 2-step procedure with 1 week interval. Dosage: number of patches depends on wound size. Application week 0 is removed after one week (week1). Week 1: wound is completely covered with new AS210 patches.

Outcomes

Primary Outcome Measures

Proportion of subjects with complete wound closure after 26 weeks.

The primary objective of this study is to demonstrate the superiority of Tiscover® compared to AS210 for achieving wound healing in subjects with a chronic (arterio) venous leg or foot ulcer.

Secondary Outcome Measures

Time in days to complete wound closure from baseline.

• Proportion of subjects with complete wound closure at each of the 12 treatment weeks.

Percentage of wound closure

Proportion of subjects with durable wound healing over the 3 months following complete wound closure

Wound size reduction

The percentage of reduction in wound area

Pain

Measured with VAS Pain scale

Quality of Life

Measured with SF 36

Number of SAE

Full Information

NCT ID

NCT02360358

First Posted

January 29, 2015

Last Updated

January 6, 2016

Sponsor

Chantal Blok

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT02360358

Brief Title

Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

Official Title

A Phase II Randomized Multicenter Study on Efficacy and Safety of Cultured Autologous Skin (Tiscover®) and Acellular Dermal Matrix (AS210) in Chronic (Arterio-)Venous Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

slow inclusion

Study Start Date

August 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chantal Blok

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A prospective, multicenter, randomised controlled phase II study in which patients with therapy resistant (arterio-) venous leg/foot ulcers are treated with Tiscover® (test group) or with AS210 (control group) to determine the safety and relative efficacy of both products.

Detailed Description

Multicenter, randomised clinical trial in out patient in which patients with chronic (arterio-) venous leg/foot ulcers are treated with an autologous cultured human living skin substitute (Tiscover®: test group) or with Acellular donor dermis (AS210: control group). During a pre-inclusion evaluation period of 4 weeks (non healing) chronicity of ulcer is ensured (ulcer size change of < 30%). To determine ulcer type ABI, Doppler and CEAP is performed. The test group will receive 2 applications of Tiscover®. Week 0: wound activating pre-treatment, application of at least one quarter of the wound surface. Week 1: removal of patches, application of patches on total wound surface. The control group (16 patients) will follow the same application protocol.

6. Conditions and Keywords

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

Varicose Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

autologous cultured skin

Arm Type

Experimental

Arm Description

Arm Title

acellular donor dermis

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tiscover

Other Intervention Name(s)

autologous skin substitute

Intervention Description

two step procedure, week 0 and week1. Dosage depends on wound size.

Intervention Type

Other

Intervention Name(s)

AS210

Other Intervention Name(s)

Acellular donor dermis

Intervention Description

two step procedure, week 0 and week1. Dosage depends on wound size.

Primary Outcome Measure Information:

Title

Proportion of subjects with complete wound closure after 26 weeks.

Description

The primary objective of this study is to demonstrate the superiority of Tiscover® compared to AS210 for achieving wound healing in subjects with a chronic (arterio) venous leg or foot ulcer.

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Time in days to complete wound closure from baseline.

Time Frame

12 weeks

Title

• Proportion of subjects with complete wound closure at each of the 12 treatment weeks.

Time Frame

12 weeks

Title

Percentage of wound closure

Time Frame

12 and 26 weeks

Title

Proportion of subjects with durable wound healing over the 3 months following complete wound closure

Time Frame

3 months and 6 months follow up

Title

Wound size reduction

Description

The percentage of reduction in wound area

Time Frame

12 and 26 weeks

Title

Pain

Description

Measured with VAS Pain scale

Time Frame

week 0, 1,2,4,8,12, 26 weeks and follow up

Title

Quality of Life

Description

Measured with SF 36

Time Frame

Week 0, 12, 26 weeks and follow up

Title

Number of SAE

Time Frame

12, 26 weeks and follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2 Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence. Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3) Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth < 1 cm Target ulcer duration ≥ 12 weeks but ≤ 15 years Acceptable state of health and nutrition Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations Exclusion Criteria: History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin. Therapy with another investigational agent within thirty (30) days of Screening, or during the study. A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit. Refusal of or inability to tolerate compression therapy. Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit. History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers). >30% change of wound size in 4 weeks or confirmed by historical data Presence of deep vein thrombosis or contra indication for compression therapy Severe co-morbidity reducing life expectance to < 1 year Use of oral corticosteroids and/or cytostatics >20 mg/per day; Severe infection of ulcer, active cellulitis, osteomyelitis Severe malnutrition Uncontrolled diabetes mellitus, HbA1c > 12% (108 mmol/mol) Anaemia Hb <6 mmol/l

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Gibss, Prof.dr.

Organizational Affiliation

VU medical center, department of dermatology

Official's Role

Study Chair

Facility Information:

Facility Name

Centrum Oosterwal

City

Alkmaar

ZIP/Postal Code

1817 MS

Country

Netherlands

Facility Name

Flevo Ziekenhuis, afdeling dermatologie

City

Almere

Country

Netherlands

Facility Name

VU University Medical center

City

Amsterdam

ZIP/Postal Code

1081HZ

Country

Netherlands

Facility Name

St. Fransiscus Gasthuis

City

Rotterdam

Country

Netherlands

Facility Name

Isala Ziekenhuis, dermatologie

City

Zwolle

Country

Netherlands

12. IPD Sharing Statement

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Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

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