Healing Time for Large Ulcers with Regen-D Ointment
Large diabetic foot ulcers treated with Regen-D ointment typically heal in 4.8 to 9 weeks, with most patients achieving complete healing by 10 weeks.
Expected Healing Timeline
The healing time for Regen-D (recombinant human epidermal growth factor) varies based on ulcer characteristics and study conditions:
Post-Marketing Real-World Data (Most Relevant)
- Average healing time: 4.8 weeks in post-marketing surveillance of 135 patients with diabetic foot ulcers 1
- Over 90% of patients healed by week 10 in real-world clinical practice 1
- This represents significantly faster healing compared to placebo (which showed only 18% healing at 10 weeks) 1
Controlled Clinical Trial Data
- Average healing time: 9 weeks in Phase III clinical trials 1
- 69% of patients healed by week 10 under controlled trial conditions 1
- Complete healing in 78% of patients within 30 days in a more recent 2020 randomized controlled trial, with mean healing time of 45 ± 12 days (approximately 6.4 weeks) 2
Factors Affecting Healing Time
The real-world post-marketing data (4.8 weeks) likely represents optimal conditions where patients received proper wound care, while the longer Phase III trial duration (9 weeks) may reflect more stringent healing criteria or more challenging ulcer characteristics 1.
Key Clinical Considerations
- Ulcer size matters: The studies primarily evaluated ulcers of varying sizes, with one study showing mean wound sizes of approximately 26-30 cm² 3
- Treatment duration: Most protocols evaluated treatment over 10-20 weeks maximum, though many patients healed much earlier 1, 4
- Quality of healing: Regen-D promotes healthy granulation tissue and epithelialization, not just wound closure 1
Important Caveats
Note that one study using platelet-derived growth factor (rhPDGF) showed no significant benefit over placebo, with 60% healing in the treatment group versus 72% in controls at 10 weeks 3. However, this contradicts other PDGF studies showing 50% complete healing versus 36% with placebo 4. The Regen-D product contains epidermal growth factor (EGF), not PDGF, and consistently demonstrates superior outcomes 1, 2.
For large ulcers specifically, expect healing times toward the longer end of the range (6-9 weeks), as the 4.8-week average likely includes smaller ulcers that heal more rapidly 1.