Condition category
Skin and Connective Tissue Diseases
Date applied
01/09/2005
Date assigned
28/10/2005
Last edited
07/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof W.A. Scherbaum

ORCID ID

Contact details

Deutsches Diabetes-Zentrum
Auf´m Hennekamp 65
Duesseldorf
40225
Germany
+49 (0)211 3382 200
scherbaum@ddz.uni-duesseldorf.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2004-4

Study information

Scientific title

Acronym

Study hypothesis

The study will evaluate the hypothesis that treatment of a chronic diabetic wound with Autologous Platelet Concentrate and Autologous Thrombin (and their autologous growth factors) has the potential to accelerate the reepithelialization process.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Lower extremity chronic diabetic ulcer

Intervention

Treatment with autologous platelet concentrate versus standard therapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Percentage of cases completely healed by 12 weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2004

Overall trial end date

30/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Patient and/or his/her legal representative has read and signed the IRB approved Informed Consent Form before treatment
3. Patient or caregiver are willing and able to participate in the clinical trial for the duration of the study and are able to visit the clinic weekly
4. Patient is willing to have blood drawn weekly
5. Patient is compliant with standard wound care regimen assessed over 3 initial observational visits each 7 days apart
6. Patient is diabetic (on insulin or oral hypoglycemic agent) HbAlC <10
7. Ulcer:
a. Ulcer present ≥4 weeks
b. Ulcer is located on lower extremity (below knee)
c. Ulcer extends through the dermis and into subcutaneous tissue and may involve tendon, muscle and/or bone
d. Ulcer size: 0.7 cm^2 to 25 cm^2
8. Circulation status:
a. Minimal disease with palpable pulses or ABI >0.7
b. Previously revascularized at least 4 weeks prior to enrolment by bypass or endovascular therapy
c. Compromised circulation with ABI 0.4-0.7 in patient not deemed to be a candidate for revascularization because of prohibitive anatomic or physiologic consideration
9. Hematological:
a. Hct ≥30%
b. Platelet count ≥100,000
10. Adequate venous access for phlebotomy
11. Reliable access to outpatient dressing care i.e. home nursing service, family member, patient
12. Serum Albumin >2.5 mg/dl
(Stratification: Wagner classification stage I or II OR stage III, creatinine clearance <40 OR ≥40, Ankle Brachial Index [ABI] 0.4-0.7 OR >0.7)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Ulcer is located in area of radiation treatment
2. Active malignancy
3. Being treated with immunosuppressant drugs
4. Patient received biological treatment(s) within 30 days
5. Active infection - if osteomyelitis has been diagnosed, patient may be enrolled only after infection has been controlled
6. Patient has a known alcohol or drug abuse
7. Patient has a non-study ulcer on the study lower extremity that is located within 2.0 cm from the study ulcer at Day 0
8. Patient has been previously diagnosed with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) or hepatitis
9. Patient is undergoing dialysis
10. Ankle Brachial Index <0.4
11. Ankle Brachial Index 0.4-0.7 in patient appropiate for revascularization
12. Venous stasis ulcers. Low leg ulcers in the presence of any of the following are to be excluded:
a. Presence of lipodermatosclerosis in the gaitor area of the calf
b. Presence of varicose veins
c. History of deep venous thrombosis in the index limb

Recruitment start date

01/12/2004

Recruitment end date

30/11/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Deutsches Diabetes-Zentrum
Duesseldorf
40225
Germany

Sponsor information

Organisation

Harvest Technologies Corp. (USA)

Sponsor details

40 Grissom Road
Suite 100
Plymouth
MA
02360
United States of America
+1 508 732 753
jbonasera@harvesttech.com

Sponsor type

Industry

Website

http://www.harvesttech.com

Funders

Funder type

Industry

Funder name

Harvest Technologies Corp.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes