Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Harvest Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers
| ISRCTN | ISRCTN28965380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28965380 |
| Secondary identifying numbers | 2004-4 |
- Submission date
- 01/09/2005
- Registration date
- 28/10/2005
- Last edited
- 12/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W.A. Scherbaum
Scientific
Scientific
Deutsches Diabetes-Zentrum
Auf´m Hennekamp 65
Duesseldorf
40225
Germany
| Phone | +49 (0)211 3382 200 |
|---|---|
| scherbaum@ddz.uni-duesseldorf.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Harvest Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lower extremity chronic diabetic ulcer |
| Intervention | Treatment with autologous platelet concentrate versus standard therapy |
| Intervention type | Other |
| Primary outcome measure | Percentage of cases completely healed by 12 weeks |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2004 |
| Completion date | 30/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 59 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 30/11/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
Deutsches Diabetes-Zentrum
Duesseldorf
40225
Germany
40225
Germany
Sponsor information
Harvest Technologies Corp. (USA)
Industry
Industry
40 Grissom Road, Suite 100
Plymouth, MA
02360
United States of America
| Phone | +1 508 732 753 |
|---|---|
| jbonasera@harvesttech.com | |
| Website | http://www.harvesttech.com |
Funders
Funder type
Industry
Harvest Technologies Corp.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2007 results presented in poster at the International Symposium on the Diabetic Foot in http://beforesurgery.com/wp-content/uploads/2016/02/info_woundcare.pdf (added 12/01/2021) |
| IPD sharing plan |
Editorial Notes
12/01/2021: The following changes have been made:
1. A poster link has been added to the publication and dissemination plan.
2. The final enrolment number has been added from the reference.
