Phase 3
Completed N=206
Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers
Source: ClinicalTrials.gov NCT00536744 ↗Enrolled (actual)
206
Serious AEs
34.5%
Results posted
Apr 2014
Primary outcomePrimary: The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application. — 22; 15 participants
Summary
The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device to sham application, when administered in conjunction with standard treatments used in the treatment of DFUs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Variable for Effectiveness of the dermaPACE Device Will be Assessed by Comparing the Incidence of Complete Wound Closure of the dermaPACE and Control Groups 12 Weeks Post Initial Application. |
22; 15 | — |
| SECONDARY Time to Wound Closure, Wound Closure Area and Volume Between Active and Control 12 Weeks Post Initial Application, Subject Pain Assessment Between Active and Control 24 Weeks Post Initial Application |
— | — |
Eligibility Criteria
Major Inclusion Criteria:
- Male or female ≥ 18 years of age
- Diabetes mellitus
- One or more chronic foot ulcers (only one will be treated) that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit
- HbA1c ≤ 12%
- Diabetic Foot Ulcers ≥ 1 cm2 and ≤ 16 cm2
- Ulcer Grade I or II, Stage A according to the University of Texas Diabetic Wound Classification system
- Ankle Brachial Index (ABI) ≥ 0.7 and ≤ 1.2, OR toe pressure > 50 mmHg, OR tcPO2> 40 mmHg.
Major Exclusion Criteria:
- Subject is morbidly obese (Body Mass Index ≥ 40)
- Subjects on dialysis
- Diagnosis of foot ulcer involving osteomyelitis
- Has evidence of prior ulcer in the same area
- Multiple diabetic foot ulcers on the foot that either are connected by fistulas or are within 5 cm of the target ulcer
- Subject's foot ulcer intended for study application has decreased in volume by 50% or more at the end of the two-week Run-in period as compared to the Screening visit.
Data sourced from ClinicalTrials.gov (NCT00536744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.