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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list