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NCT00605189 Clinical Trial

A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

Diabetic Foot Ulcers Clinical Trial

Official title:
A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00605189
Other study ID # VACP2005-009
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 2007
Est. completion date November 2010

Study information
Verified date July 2022
Source 3M
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Type II diabetes - Subject has a diabetic foot ulcer 5cm squared or greater - Subject's diabetic foot ulcer is chronic Exclusion Criteria: - HgbA1c of 12% or greater - Presence of cellulitis - Presence of osteomyelitis

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Powered Suction Pump (VAC Freedom)
continuous foam based negative pressure wound therapy
• Powered Suction Pump
continuous gauze based negative pressure wound therapy
• MWT
moist wound therapy

Locations
Country Name City State
United States The Ohio State University Medical Center Columbus Ohio
United States University of Texas Health Science Center San Antonio San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare Energy Charge Between Wound Treatment Therapies Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit.
Energy Charge is calculated as follows:
Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP)
Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate		 Day 0, Day 2, Day 7
See also
  Status Clinical Trial Phase
Completed NCT02652754 - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers Phase 1
Completed NCT01070433 - A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers Phase 2
Completed NCT00971048 - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds N/A
Terminated NCT00762138 - The AutoloGel™ Post-Market Surveillance (TAPS) Program N/A
Completed NCT00578604 - Non-Invasive Assessment of Wound Healing With Optical Methods N/A
Completed NCT05417425 - Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers Phase 1
Completed NCT02631512 - Evaluation of Woulgan in Diabetic Foot Ulcer Phase 4
Terminated NCT01816633 - Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers N/A
Completed NCT02222376 - Effect of Topic Pirfenidone in Diabetic Ulcers Phase 3
Completed NCT01454401 - LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers N/A
Completed NCT01221207 - Instant Total Contact Cast to Heal Diabetic Foot Ulcers N/A
Completed NCT01291160 - Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers Phase 2/Phase 3
Withdrawn NCT01105884 - Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers N/A
Completed NCT00536744 - Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers Phase 3
Terminated NCT00316537 - Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers Phase 1/Phase 2
Completed NCT00013299 - Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 Phase 2
Completed NCT00013286 - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk Phase 2
Terminated NCT02667327 - A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer Phase 3
Not yet recruiting NCT00916292 - Safety Study of Topical Human FGF-1 for Wound Healing Phase 1
Completed NCT01154374 - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot) Phase 2